May 3, 2024

Philips Healthcare (Suzhou) Co., Ltd.

℅ An Shiguang
Regulatory Affairs Manager
No. 258, Zhongyuan Road, Suzhou Industrial Park
SUZHOU JIANGSU, CHINA, 215024

Re: K232491
Trade/Device Name: CT 5300
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: April 4, 2024
Received: April 4, 2024

Dear An Shiguang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.09
Silver Spring, MD 20993
www.fda.gov
K232491 - An Shiguang Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 07/31/2026
Indications for Use See PRA Statement below.

510(k) Number (if known)

K232491

Device Name
CT 5300

Indications for Use (Describe)

The CT 5300 is a Computed Tomography X-Ray System intended to produce images of the head and body by computer
reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis
and display equipment, patient and equipment supports, components and accessories. The CT 5300 is indicated for head,
whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early
detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion
criteria of programs / protocols that have been approved and published by either a governmental body or professional
medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011;
365:395-409) and subsequent literature, for further information.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 K232491

Traditional 510(k)

510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92(c)]
Date Prepared: Mar 8, 2024
Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industrial Park,
Suzhou Jiangsu, CHINA, 215024
Establishment Registration Number: 3009529630

Additional Manufacturing Site:

Philips Medical Systems Technologies, LTD.
Advanced Technology Center MATAM, Building 34,
3100202 Haifa Israel.
Establishment Registration Number: 9617978
Primary Contact Shiguang An
Person: Regulatory Affairs Engineer
Phone: +86-0-13940106467
E-mail: [email protected]

Secondary Contact Erhong Wang

Person Senior Manager Regulatory Affairs
Phone : +86-0-13021019589
E-mail : [email protected]
Device Name: CT 5300
Classification: Classification name: Computed tomography x-ray
system
Classification Regulation: 21CFR 892.1750
Classification Panel: Radiology
Device Class: Class II
Primary Product Code: JAK
Primary Predicate Trade name: Philips Incisive CT
Device: Manufacturer: Philips Healthcare (Suzhou)
Co., Ltd.
510(k) Clearance: K212441
Classification Regulation: 21CFR 892.1750
Classification name: Computed tomography x-ray
system
Classification Panel: Radiology
Device class Class II
Product Code: JAK

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 1 of 16
 Traditional 510(k)
Device Description: The proposed device is a whole-body computed
tomography (CT) X-Ray System featuring a continuously
rotating x-ray tube, detectors, and gantry with multi-slice
capability. The acquired x-ray transmission data is
reconstructed by computer into cross-sectional images of
the body taken at different angles and planes. This system
also includes signal analysis and display equipment, patient
and equipment supports, components, and accessories.
The CT 5300 has a 72 cm bore and includes a detector
array that provides 50 cm scan field of view (FOV).
The main components (detection system, the reconstruction
algorithm, and the x-ray system) that are used in the
proposed device have the same fundamental design
characteristics and are based on comparable technologies
as the current marketed predicate Philips Incisive CT
K212441(April 27, 2022).
The key system modules and functionalities are:
1. Gantry
The Gantry consists of 4 main internal units:
a. X-Ray Tube – produces X-rays necessary for
scanning.
b. High voltage generator - produces high voltage
power supply to X-ray tube, consists of system
Interface Unit, Power Block Unit and Anode Drive
Unit.
c. A-plane: adjusts the slice thickness during axial
scan and monitor the changes of X-ray.
d. DMS (Data Management System) – absorbs X-ray
radiation by detectors and converts it to digital
readout.
2. Patient Table (Couch)
The Couch is used to position the patient. Carries the
patient in and out through the Gantry bore synchronized
with the scan.
3. Console
The console is used to operate the system and monitor
the scan. The Operator console includes a computer,
monitors and CTBOX.
4. CT on Trailer Kit
The CT 5300 installed and secured on a trailer requires
locking motion parts during trailer transportation and
unlocking motion parts before CT operations. Besides
being installed in hospital, the CT may also be installed on
trailer to be transported to designated locations for use
within a professional healthcare environment.
Premarket Notification [510(k)] Submission
Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 2 of 16
 Traditional 510(k)
The CT 5300 on Trailer Kit has the same fundamental
design characteristics and technologies as the current
marketed Philips Incisive CT on trailer (K211168 -
November 22, 2021). The CT on Trailer configuration is
identical to the K211168 trailer configuration. The CT
system should only be used in designated locations for
use with appropriate radiation controls and safety
measures.

In addition to the above components and the software

operating them, each system includes hardware and
software for data acquisition, display, manipulation, storage
and filming as well as post-processing into views other than
the original axial images.

Upgrades Kit is available to upgrade earlier Incisive CT

installations to latest version.

Indications for Use: The CT 5300 is a Computed Tomography X-Ray System

intended to produce images of the head and body by
computer reconstruction of x-ray transmission data taken at
different angles and planes. These devices may include
signal analysis and display equipment, patient and
equipment supports, components and accessories. The CT
5300 is indicated for head, whole body, cardiac and
vascular X-ray Computed Tomography applications in
patients of all ages.

These scanners are intended to be used for diagnostic

imaging and for low dose CT lung cancer screening for the
early detection of lung nodules that may represent cancer*.
The screening must be performed within the established
inclusion criteria of programs / protocols that have been
approved and published by either a governmental body or
professional medical society.

*Please refer to clinical literature, including the results of the

National Lung Screening Trial (N Engl J Med 2011;
365:395-409) and subsequent literature, for further
information.

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 3 of 16
 Traditional 510(k)
Fundamental The proposed device is an advanced continuous rotation
Scientific computed tomography system suitable for a wide range of
Technology: computed tomographic (CT) applications.
The proposed device is used clinically as a diagnostic
patient imaging device that produces images that
correspond to tissue density. The quality of the images
depends on the level and amount of X-ray energy delivered
to the tissue. CT imaging displays both high-density tissue,
such as bone, and soft tissue.
The principal technological components (rotating x-ray tube,
detector and gantry) of the proposed device are
substantially equivalent to the currently marketed predicate
device Philips Incisive CT (K212441 (April 27, 2022).
Based on the information provided above, the proposed
device does not raise different questions of safety and
effectiveness compared to the currently marketed predicate
device Philips Incisive CT (K212441(April 27, 2022).

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 4 of 16
 Traditional 510(k)
Summary of Non- The proposed device conforms to international standards,
Clinical Performance FDA-recognized consensus standards, 21 CFR Subchapter-
Data: J performance standards, NEMA industry standards, and
FDA guidance documents.

• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,

C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated
Text) [Incl. AMD2:2021] Medical Electrical Equipment - Part
1: General Requirements for Basic Safety and Essential
Performance (IEC 60601-1:2005, MOD) [Incl. AMD2:2021].
FDA/CDRH recognition number 19-46

• IEC 60601-1-2:2020 (Consolidated Text) Medical

electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances – Requirements
and tests
FDA/CDRH recognition number 19-36

• IEC 60601-1-3:2021(Consolidated Text) Medical electrical

equipment -- Part 1-3: General requirements for basic safety
- Collateral standard: Radiation protection in diagnostic X-
ray equipment
FDA/CDRH recognition number 12-336

• IEC 60601-1-6:2020(Consolidated Text) Medical electrical

equipment -- Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability
FDA/CDRH recognition number 5-132

• IEC 60601-2-44:2016 Medical electrical equipment - Part

2-44: Particular requirements for the safety and essential
performance of X-ray equipment for computed tomography
FDA/CDRH recognition number 12-302

• IEC 62304:2015 (Consolidated Text) Medical device

software -- Software life cycle processes
FDA/CDRH recognition number 13-79

•IEC 62366-1:2020 Medical devices -- Part 1: Application of

usability engineering to medical devices
FDA/CDRH recognition number 5-129

• ISO14971:2019 Medical devices – Application of risk

management to medical devices
FDA/CDRH recognition number 5-125

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 5 of 16
 Traditional 510(k)
• ISO 10993-1:2018 Biological evaluation of medical
devices – Part 1: Evaluation and testing within a risk
management process
FDA/CDRH recognition number 2-258

• NEMA XR 25-2019 Computed Tomography Dose Check

FDA/CDRH recognition number 12-325

• NEMA XR 26:2020 Access Controls for Computed

Tomography: Identification, Interlocks, and Logs

• NEMA XR 28-2018 Supplemental Requirements for User

Information and System Function Related to Dose in CT
FDA/CDRH recognition number 12-330

• NEMA XR 29-2013 Standard Attributes on CT Equipment

Related to Dose Optimization and Management

• Guidance for Industry and FDA Staff – Guidance for the

Content of Premarket Submissions for Device Software
functions
(Issued June 14, 2023, document number GUI00000337).

• Guidance for Industry and FDA Staff – Cybersecurity in

Medical Devices: Quality System Considerations and
Content of Premarket Submissions (issued September 27,
2023, document number GUI00001825)

• Guidance for Industry and FDA Staff – Use of International

Standard ISO 10993-1, "Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk
management process" (issued September 4, 2020,
document number 1811-R1)

• Guidance for Industry and Food and Drug Administration

Staff – Electromagnetic Compatibility (EMC) of Medical
Devices: (issued June 6, 2022, document number 1400057)

• Performance standards for Computed Tomography (CT)

Equipment and Laser products (21 CFR 1020.33 and 21
CFR 1040.10, respectively).

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 6 of 16
 Traditional 510(k)

Non-Clinical verification and or validation tests have been

performed with regards to the intended use, the technical
claims, the requirement specifications and the risk
management results.

Non- Clinical verification and or validation test results

demonstrate that the proposed device:
• Complies with the aforementioned international
standards, FDA-recognized consensus standards,
Subchapter-J performance standards, NEMA
industry standards and FDA guidance documents.
• Meets the acceptance criteria and is adequate for its
intended use.

Precise Image (K210760) was modified for use in the CT

5300 system. With no changes to the algorithm architecture,
new models were introduced to enable the reconstruction of
a new organ type (cardiac), support more slice thickness
and increment combinations, a new scan mode (high
resolution head), and more clinical scenarios for body and
head. All models were adequately trained and successfully
compared using half-dose Precise Image reconstructions
with full-dose iDose4 reconstructions. The comparative
image quality assessment using phantoms demonstrated
acceptable performance for the new models used in Precise
Image. Additionally, a comparative image evaluation by two
US Board Certified Radiologists of 126 image set pairs
(including cases with pathology) comprising 31 unique
patients representing the newly supported reconstructions.
The comparative image assessment demonstrated that half-
dose images processed by Precise Image in CT 5300,
including both new and original existing models, are of
equal or greater diagnostic quality compared to full dose
images processed by iDose4.
The comparative external image assessment confirms the
validity of successful bench testing and clinical image
quality evaluations, and when taken together, demonstrate
Precise Image in CT 5300 to be as safe and effective as the
predicate, and thus substantially equivalent to Precise
Image (K210760) in predicate Incisive CT (K212441).

Precise Position (originally cleared in K203514) was

modified for use in the CT 5300 with no change to the

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 7 of 16
 Traditional 510(k)
design of the AI algorithm, the body joints detection
algorithm including CNN architecture, model parameters,
inference pipeline, pre- and post-processing is same as
what is used in the predicate Incisive CT. The original model
was trained using a broad dataset and performance data
using clinical images demonstrate the model can further
support more exams (cardiac, spine, runoff).
Evaluation/assessment of the modified Precise Position
algorithm, system level verification and validation activities
have been properly carried out to demonstrate it is as safe
and effective as the predicate to process the newly
integrated exams (cardiac, spine, runoff), hence the
modified Precise Position in the CT 5300 is substantially
equivalent to the predicate Incisive CT (K212441), which
integrates Precise Position (originally cleared in K203514).

Therefore, the proposed device is substantially equivalent to

the primary currently marketed and predicate device
Predicate Philips Incisive CT (K212441(April 27, 2022) in
terms of safety and effectiveness.

Summary of Clinical The proposed device did not require clinical study since
Data: substantial equivalence to the legally marketed predicate
device was proven with the verification/validation testing,
bench testing, retrospective clinical data, and other
evidence as outlined

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 8 of 16
 Traditional 510(k)

Substantial Equivalence

Substantial equivalence is established through comparison of features and functions of

the proposed CT 5300 device and predicate Philips Incisive CT (K212441).

Scan Characteristics Comparison

Proposed CT 5300 Predicate Philips Conclusion
device Incisive CT (K212441)

Identical.
No. of Slices 64/128 64/128 Therefore, substantially
equivalent.
Surview Surview Identical.
Therefore, substantially
Scan Modes Axial Scan Axial Scan
equivalent.
Helical Scan Helical Scan

Minimum Scan 0.35 sec for 360° rotation 0.35 sec for 360° rotation Identical.
Time Therefore, substantially
equivalent.
Image (Spatial) High resolution mode: 16 High resolution mode: 16 Identical.
Resolution lp/cm lp/cm Therefore, substantially
equivalent.
Standard resolution Standard resolution
mode: 13 lp/cm mode: 13 lp/cm

Image Noise 0.27% at 120 kV, 230 0.27% at 120 kV, 230 Identical.
mAs, 10 mm slice mAs, 10 mm slice Therefore, substantially
equivalent.
thickness thickness

Slice Helical: 0.67mm – 5mm Helical: 0.67mm – 5mm Identical.

Thicknesses Therefore, substantially
Axial: 0.625 mm – Axial: 0.625 mm –
equivalent.
10.0mm 10.0mm

Scan Field of Up to 500 mm Up to 500 mm Identical.

View Therefore, substantially
equivalent.
Image Matrix Up to 1024 * 1024 Up to 1024 * 1024 Identical.
Therefore, substantially
equivalent.
Display 1920 * 1080 1920 * 1080 Identical.

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 9 of 16
 Traditional 510(k)
Therefore, substantially
equivalent.
Host Windows 10 Windows 10 Identical.
Infrastructure Therefore, substantially
equivalent.
Communication Compliance with DICOM Compliance with DICOM Identical.

Therefore, substantially
equivalent.
Dose Reporting Compliance with NEMA Compliance with NEMA Compliance with more
NEMA standard.
and XR25, XR26, XR28 and XR25, XR28 and XR29
Management XR29 Safety and
effectiveness are not
affected.

Therefore,
demonstrating
substantial
equivalence.

Software or Imaging Features Comparison

Same feature
cleared in Conclusion
CT 5300
Predicate (Function/ User
Features Feature description
Philips interface/
Name
Incisive CT Workflow)
(K212441)
2D Viewer In 2D Viewer mode operator can review Yes Identical.
original axial images as acquired by the
Therefore,
scanner.
substantially
equivalent.
MPR Use the MPR mode to view three-plane Yes Identical.
orthogonal images. In this mode, the three Therefore,
shown planes can be easily correlated. substantially
Three orthogonal cut planes are shown: equivalent.
• Axial Orientation

• Coronal Orientation

• Sagittal Orientation

3D (volume The volume mode is used to display CT Yes Identical.

mode) scanner data in a full volume image. It
provides basic tools for image editing and
generation of cine movies.

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 10 of 16
 Traditional 510(k)
Therefore,
substantially
equivalent.
Virtual The CT Endo viewer is a review function Yes Identical.
Endoscopy that allows you to perform a general
Therefore,
flythrough of any suitable anatomical
(Endo) substantially
structure that is filled with air or with
equivalent.
contrast material, including general vessels,
cardiac vessels, the bronchus, and the
colon.
Image matrix The Image Matrix parameter sets the Yes Identical.
number of pixels that the reconstructed
Therefore,
image will contain. Select 512, 768, or
substantially
1024.
equivalent.
O-MAR O-MAR stands for orthopedic metal artifact Yes Identical.
reduction. This post processing capability
Therefore,
reduces metal induced artifacts and is
substantially
directed for large orthopedics metals that
equivalent.
cause photon starvation of the rays that
pass through the metal object.
DoseRight DoseRight Index (DRI) is according to the Yes Identical.
Index current scan site and body size of the
Therefore,
(DRI) patient, the mAs suitable for the patient is
substantially
automatically recommended, so that the
equivalent.
image quality can meet the requirements of
the diagnosis, and the radiation dose of the
patient can be reduced as far as possible.
DOM DOM combines angular and longitudinal Yes Identical.
information to modulate dose in three
Therefore,
dimensions. Personalizes dose for each
substantially
patient by automatically suggesting tube
equivalent.
current settings according to the estimated
patient diameter in the scan region. Angular
dose modulation varies the tube current
during helical scans according to changes
in patient shape (eccentricity) and tissue
attenuation as the tube rotates.
Precise Precise Planning can automatically adjust Yes Identical.
Planning the scan range of subsequent Axial or
Therefore,
Helical scan series, based on the Surview
substantially
Image.
equivalent.
Oblique Support the adjustment of sagittal / coronal Yes Revised feature,
image construction in the planned scanning on the basis of the
MPR phase, and finally obtain the adjusted tilted (It is called cleared “Insert
multiplane image. MPR”, added the
“Insert MPR” in
ability for users to
On the basis of Insert MPR, surface predicate tilt the MPR
reconstruction is carried out by interpolation image.
device)
of axial image and corresponding tilted
Safety and
image is generated.
effectiveness are
not affected.

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 11 of 16
 Traditional 510(k)
Therefore,
substantially
equivalent.
OnPlan OnPlan is a gantry operational touch panel Yes Identical.
located on both sides of the gantry. The
Therefore,
OnPlan gantry controls are used to activate
substantially
the laser marker, controls patient table
equivalent.
movements, display patient information and
images, and conduct a new patient exam.
Precise Precise Spine application enables the Yes Identical.
Spine system to assist the user to identify the Therefore,
lumbar disk space automatically and create substantially
a batch based on the protocol selected. equivalent.
Precise Precise Brain application for a series of Yes Identical.
Brain brain tissue slices that are parallel or Therefore,
vertical in the plane of the cranial CT scan. substantially
equivalent.
Bolus The Bolus tracking function maximizes the Yes Identical.
efficiency of CT scans that are enhanced
Tracking Therefore,
through the use of a contrast agent. This is
substantially
done by preceding the Clinical scan with
equivalent.
Locator and Tracker scans.
SAS (Spiral This feature enables the usage of the Yes Identical.
Auto Start) injector scan trigger. Therefore,
substantially
equivalent.
Filming The Filming application is used for viewing, Yes Identical.
rearranging, windowing and zooming Therefore,
images prior to sending them to be printed. substantially
equivalent.

Worklist The Worklist displays patient information Yes Identical.

provided by the HIS/RIS. Therefore,
substantially
equivalent.
MPPS If the patient is from the Worklist and the Yes Identical.
MPPS function is enabled, feedback
Therefore,
regarding the study status of the patient can
substantially
be sent to the hospital HIS/RIS.
equivalent.
Reporting The Reporting package allows you to create Yes Identical.
customized reports using pre-formatted
Therefore,
templates.
substantially
A template is a specially designed
equivalent.
formatting document that places the
analytical information and images that you
send from an application into an organized
report which can be printed and saved.
CCT Continuous CT (CCT) is a scanning mode Yes Identical.
(Continuous that allows the physician to perform
CT)

Premarket Notification [510(k)] Submission

Philips Healthcare (Suzhou) Co., Ltd. 510(k) Summary
CT 5300 Page 12 of 16
 Traditional 510(k)
extended, low-dose scans while performing Therefore,
a biopsy. substantially
The resulting images are displayed on a equivalent.
remote monitor in the scan room, providing
visual feedback during the biopsy.
Brain Brain Perfusion is a blood flow imaging Yes Identical.
application that analyzes the uptake of
Perfusion Therefore,
injected contrast in order to determine
substantially
perfusion-related information about one or
equivalent.
more regions of interest.
Dental Dental applications are used to create true- Yes Identical.
size (life size) film images of the mandible
(Dental Therefore,
and maxilla for assisting oral surgeons in
substantially
planning) planning implantation of prostheses. Using
equivalent.
a special dental planning procedure, the
images will be created from this scan which
can be input into the Dental planning
application.
iDose4 iDose4 is an iterative reconstruction Yes Identical.
technique that improves image quality
Therefore,
through artifact prevention and increased
substantially
spatial resolution at low dose.
equivalent.
Helical Helical retrospective cardiac scanning Yes Identical.
Retrospectiv enables the system to acquire a volume of
Therefore,
data while the patient’s ECG is recorded.
-e Tagging substantially
The acquired data is tagged and
equivalent.
reconstructed retrospectively at any desired
phase of the cardiac cycle.
Axial Axial prospective gating uses an external Yes Identical.
Prospective ECG gating system to synchronize
Therefore,
individual axial scans with the patient’s
Gating substantially
heartbeat. The ECG-triggered scans
equivalent.
calcium significantly minimize heart-motion artifacts.
scoring
Step & Step & Shoot Cardiac provides high quality Yes Identical.
CT images of the coronary arteries and
Shoot Therefore,
heart anatomy at very low radiation dose
substantially
levels. During Step & Shoot Cardiac, X-rays
equivalent.
are generated only during the cardiac phase
of interest.
CCS The Cardiac Calcium Scoring application is Yes Identical.
(Cardiac used to quantify the buildup of calcium
Therefore,
plaque on the walls of the patient's coronary
calcium substantially
arteries and other relevant locations. The
scoring) equivalent.
potential calcifications are highlighted by the
application during launch.
Precise Precise image reconstruction is a recon Yes Same AI/ML
image mode where the system uses a trained image recon
deep learning neural network to generate algorithm,
noise reduction images compared with modified with new
standard FBP recon mode for adult models to enable
patients only. Precise Image has not been the reconstruction
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CT 5300 Page 13 of 16
 Traditional 510(k)
validated for lung cancer screening of a new organ
type (cardiac),
indications.
support more slice
thicknesses, a
new scan mode
(high resolution
head), and more
clinical scenarios
for body and
head.
No change to
algorithm
architecture
compared to
predicate device,
therefore,
substantially
equivalent.
Precise Precise Cardiac is a reconstruction Yes Identical.
cardiac technique with the potential to
Therefore,
provide compensation for cardiac motion.
substantially
equivalent.
Precise Precise Position is a camera-based Yes Same AI/ML
position workflow designed to assist with positioning algorithm,
the patients aged 16 years and older modified to
automatically from console or OnPlan, it support more
can: exams (cardiac,
• automatically select patient orientation. spine, runoff).
• automatically set vertical centering & No change to
positioning of the patient to the Surview algorithm
start and end positions. architecture
compared to
• support editing Surview start & end range
predicate device,
and scan direction.
therefore,
substantially
equivalent.
Precise In Precise Intervention viewer there are Yes Same
intervention several tools, they will help you to navigate interventional
the needle safely during the intervention. feature as
predicate device.
To duplicate one
additional
Interventional
controls panel
from couch side to
a mobile cart for
convenience.
There is no
change to SW
algorithm

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CT 5300 Page 14 of 16
 Traditional 510(k)
compared to
predicate device.
Therefore,
substantially
equivalent.
Direct Direct Result-With Direct Result the user is Yes Identical.
results able to choose a desired result during scan Therefore,
planning phase and get the result for substantially
diagnosis without equivalent.
further intervention.
Parallel The system support Parallel workflow using Yes Identical.
workflow Dual monitor as below: Therefore,
- main monitor: Patients, scan, service, substantially
"show all" for scan planning, Help. equivalent.
- extend monitor: Completed, viewers,
Analysis, recon, filming, report
CTC (CT CT Colonoscopy (CTC) application enables Yes Identical.
fast and easy visualization of colon scans,
Colonoscopy) using acquired CT images. Therefore,
substantially
equivalent.
VA (Vessel Vessel Analysis (VA) offers a set of tools for Yes Identical.
general vascular analysis. With VA the user
Analysis) can easily remove bone, and extract Therefore,
vessels. Users also can perform substantially
measurements such as intraluminal equivalent.
diameter, cross-sectional lumen area,
length.
LNA (Lung The Lung Nodule Analysis (LNA) Yes Identical.
Nodule application assists the radiologist with the
detection and quantification of pulmonary Therefore,
Analysis) substantially
nodules and lesions.
equivalent.
CAA The Coronary Artery Analysis provides Yes Identical.
(Cardiac viewing and measuring tools that allow you
to perform dimensional and quantitative Therefore,
Artery substantially
measurements of the coronary arteries to
Analysis) help you identify and examine the patient equivalent.
study for stenosis.
CFA Cardiac Function Analysis (CFA) application Yes Identical.
(Cardiac is used to assess the state of the left
ventricle (LV) and to analyze functional Therefore,
Function substantially
heart data.
Analysis) equivalent.
Dual Energy Dual energy Viewer is an application for Yes Identical.
review and analysis of CT dual-energy
Therefore,
scans. Users need to load CT dual-
substantially
energy scan data which is two series
equivalent.
with similar KV. It provides registration
function and can generate different

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CT 5300 Page 15 of 16
 Traditional 510(k)
weighted KV images. Users can use the
tools to separate materials.
Substantial The CT 5300 system design, intended use, technology and principal
Equivalence technological components (Tube, Generator, Detector) of the proposed
Conclusion: device are substantially equivalent to the currently marketed predicate
device Philips Incisive CT (K212441 - April 27, 2021). Based on the
information provided above, the proposed device with modifications does
not raise new questions of safety and effectiveness compared to the
currently marketed predicate device Philips Incisive CT (K212441 - April
27, 2022).

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