Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard CT system and its components, focusing on hardware and basic image reconstruction. There is no mention of AI, ML, or any advanced algorithms that would typically indicate their use. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".

Therapeutic

No.
The device is described as being used for "diagnostic imaging" and "low dose CT lung cancer screening," which are diagnostic rather than therapeutic purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "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*."

SaMD (Software as a Medical Device)

No

The device description explicitly details numerous hardware components including a gantry, x-ray tube, detectors, patient support, and console, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided text, the Incisive CT is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Incisive CT Function: The Incisive CT is a Computed Tomography X-Ray System. It works by using X-rays to create images of the internal structures of the body. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it's for producing images of the head and body by computer reconstruction of x-ray transmission data. This is an imaging modality, not an in vitro test.

Therefore, the Incisive CT falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Incisive CT 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 Incisive CT 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.

Product codes (comma separated list FDA assigned to the subject device)

JAK

Device Description

The proposed Philips Incisive CT 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 Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV).
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Ingenuity CT (K160743, 08/08/2016).
The main system modules and functionalities are:

Gantry. The Gantry consists of 4 main internal units:
a. Stator - a fixed mechanical frame that carries HW and SW
b. Rotor - A rotating circular stiff frame that is mounted in and supported by the stator.
c. X-Ray Tube (XRT) and Generator,- fixed to the Rotor frame
d. Data Measurement System (DMS) - a detectors array, fixed to the Rotor frame
Patient Support (Couch) - carries the patient in and out through the Gantry bore synchronized with the scan
Console - Containing a Host computer and display that is the primary user interface.
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. Patient supports (positioning aids) are used to position the patient.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray Computed Tomography

Anatomical Site

head, whole body, cardiac, vascular, lung

Indicated Patient Age Range

patients of all ages

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed Philips Incisive CT did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
Clinical and phantom sample images were provided to support the ability of proposed Philips Incisive CT to generate diagnostic quality images.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160743

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K091195, K162025, K090462

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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Philips Healthcare (Suzhou) Co., Ltd. % Shiguang An Regulatory Affairs Engineer No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA

March 20, 2018

Re: K180015

Trade/Device Name: Philips Incisive CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 27, 2017 Received: January 2, 2018

Dear Shiguang An:

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 (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. 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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Philips Incisive CT

Indications for Use (Describe)

The Incisive CT 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 Incisive CT 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.

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FORM FDA 3881 (7/17)

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510(k) Summary of Safety and Effectiveness [As required by 21 CFR 807.92(c)]

Date Prepared:	December 15, 2017
Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.
	No. 258, Zhongyuan Road, Suzhou Industrial Park,
	Suzhou Jiangsu, CHINA, 215024
	Establishment Registration Number: 3009529630
Primary Contact
Person:	Shiguang An
Regulatory Affairs Engineer
Phone: +86-24-28206367
E-mail: shiguang.an@philips.com
Secondary Contact
Person	Gordon Shu
Senior Regulatory Manager
Phone: +86-512-67336804
E-mail: Gordon.Shu@philips.com
Device Name:	Philips Incisive CT
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
Device:	Trade name:	Philips Ingenuity CT
	Manufacturer:	Philips Medical Systems
(Cleveland), Inc.
	510(k) Clearance:	K160743
	Classification Regulation:	21CFR 892.1750
	Classification name:	Computed tomography x-ray system
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	JAK
Reference Predicate
Device:	Trade name:	Philips MX 16 SLICE
	Manufacturer:	Philips Medical Systems
(Cleveland), Inc.
	510(k) Clearance:	K091195
	Classification Regulation:	21CFR 892.1750
	Classification name:	Computed tomography x-ray system
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	JAK
Reference Predicate	Trade name:	IntelliSpace Portal Platform
Device:	Manufacturer:	Philips Medical Systems
Nederlands B.V.
	510(k) Clearance:	K162025
	Classification Regulation:	21CFR 892.2050
	Classification name:	system, image processing,
radiological
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	LLZ
Reference Predicate
Device:	Trade name:	BRILLIANCE DUAL ENERGY
OPTION
	Manufacturer:	Philips Medical Systems
(Cleveland), Inc.
	510(k) Clearance:	K090462
	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. Philips Incisive CT

Section 5-510(k) Summary Page 1 of 16

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5

Device Description:	The proposed Philips Incisive CT 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 Philips Incisive CT has a 72cm bore and includes a
	detector array that provides 50cm scan field of view (FOV).
	The main components (detection system, the reconstruction
algorithm, and the x-ray system) that are used in the
	proposed Philips Incisive CT have the same fundamental
	design characteristics and are based on comparable
	technologies as the current market predicate Philips
	Ingenuity CT (K160743, 08/08/2016).
	The main system modules and functionalities are:
	1. Gantry. The Gantry consists of 4 main internal units:
	a. Stator - a fixed mechanical frame that carries HW
and SW
	b. Rotor - A rotating circular stiff frame that is
	mounted in and supported by the stator.
	c. X-Ray Tube (XRT) and Generator,- fixed to the
Rotor frame
	d. Data Measurement System (DMS) - a detectors
array, fixed to the Rotor frame
	2. Patient Support (Couch) - carries the patient in and out
	through the Gantry bore synchronized with the scan
	3. Console - Containing a Host computer and display that is
	the primary user interface.
	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. Patient supports (positioning aids)
	are used to position the patient.
Indications for Use:	Traditional 510
	The Incisive CT 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
Incisive CT 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.
Fundamental
Scientific
Technology:	The proposed Philips Incisive CT is advanced continuous-
rotation computed tomography systems suitable for a wide
range of computed tomographic (CT) applications.
	The proposed Philips Incisive CT 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 Philips Incisive CT
substantially equivalent to the currently marketed predicate
device Philips Ingenuity CT (K160743, 08/08/2016)
	Based on the information provided above, the proposed
Philips Incisive CT does not raise different questions of
safety and effectiveness compare to the currently marketed
predicate device Philips Ingenuity CT (K160743,
08/08/2016).
Summary of Non-Clinical Performance Data:	The proposed Philips Incisive CT comply with the following international and FDA-recognized consensus standards:	Traditional 510
	• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD).
FDA/CDRH recognition number 19-4
	• IEC 60601-1-2:2014, 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 19-8
	• IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment
FDA/CDRH recognition number 12-269
	• IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
FDA/CDRH recognition number 5-89
	• IEC 60601-2-44:2012 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment
FDA/CDRH recognition number 12-256
	• IEC 62304:2015 Medical device software -- Software life cycle processes
FDA/CDRH recognition number 13-79
	• IEC 62366:2014 Medical Device-Application of Usability Engineering of Medical Devices
FDA/CDRH recognition number 5-87
	• ISO14971 Medical devices - Application of risk management to medical devices (Ed. 2.0, 2007)
FDA/CDRH recognition number 5-40
	• NEMA XR 25-2010 Computed Tomography Dose Check
FDA/CDRH recognition number 12-225

6

7

8

Traditional 510(k
• NEMA XR 28-2013 Supplemental Requirements for User
Information and System Function Related to Dose in CT
FDA/CDRH recognition number 12-287
• 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 Software Contained
in Medical Devices
(issued May 11, 2005, document number 337).
• Guidance for Industry and FDA Staff – Content of
Premarket Submissions for Management of Cybersecurity in
Medical Devices (issued October 2, 2014)
• 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 June 16, 2016)
• Guidance for Industry and FDA Staff – Information to
Support a Claim of Electromagnetic Compatibility (EMC) of
Electrically-Powered Medical Devices (issued July 11, 2016)
The systems comply with industry guidance and
performance standards for Computed Tomography (CT)
Equipment and Laser products (21 CFR 1020.33 and 21
CFR 1040.10, respectively).
The systems performed a comparison to the predicate using
these technological characteristics and image quality
metrics to establish that the subject device is substantially
equivalent to the predicate for its intended use, which
includes low dose CT lung cancer screening among more
general diagnostic imaging indications.
The test results demonstrate that the proposed Philips
Incisive CT meets the acceptance criteria and is adequate
for its intended use. Additionally, the risk management
activities show that all risks are sufficiently mitigated, that no
new risks are introduced, and that the overall residual risks
are acceptable.

Philips Healthcare (Suzhou) Co., Ltd.

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| Summary of Clinical
Data: | The proposed Philips Incisive CT did not require clinical
study since substantial equivalence to the legally marketed
predicate device was proven with the verification/validation
testing. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinical and phantom sample images were provided to
support the ability of proposed Philips Incisive CT to
generate diagnostic quality images. |

Substantial Equivalence

Scan Characteristics Comparison
Scan
characteristics	Proposed Philips
Incisive CT	Predicate Device
Philips Ingenuity
CT(K160743)	Conclusion
No. of Slices	64/128	64/128	Identical.
Therefore, substantially
equivalent.
Scan Modes	Surview
Axial Scan
Helical Scan	Surview
Axial Scan
Helical Scan	Identical.
Therefore, substantially
equivalent.
Minimum Scan
Time	0.35 sec for 360°
rotation	0.42 sec for 360° rotation	The proposed Philips
Incisive CT rotation
speed faster than
Ingenuity CT to meet the
wider heart rate
application.
Safety and effectiveness
are not affected.
Therefore,
demonstrating
substantial
equivalence.
Image (Spatial)
Resolution	High resolution mode:
16 lp/cm
Standard resolution	High resolution mode:16
lp/cm
Standard resolution mode:	Identical.
Therefore, substantially
equivalent.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT

Section 5-510(k) Summary
Page 7 of 16

10

Philips Healthcare (Suzhou) Co., Ltd.

Traditional 510(k)

	mode: 13 lp/cm	13 lp/cm
Image Noise	0.27% at 120 kV, 230 mAs, 10 mm slice thickness	0.27% at 120 kV, 250 mAs, 10 mm slice thickness	Identical.
Therefore, substantially equivalent.
Slice
Thicknesses	Helical: 0.67mm – 5mm
Axial: 0.625mm – 10.0mm	Helical: 0.67mm – 5mm
Axial: 0.625mm – 12.5mm	Essentially the same slice thickness, does not affect safety and effectiveness.
Therefore, demonstrating substantial equivalence.
Scan Field of View	Up to 500 mm	Up to 500 mm	Identical.
Therefore, substantially equivalent.
Image Matrix	Up to 1024 * 1024	Up to 1024 * 1024	Identical.
Therefore, substantially equivalent.

Imaging Features Comparison
Proposed
Philips
Incisive CT
Features	Feature description	Predicate Device
PHILIPS Ingenuity
CT (K160743)	Conclusion
(Function/ User
interface/
Workflow)
2D Viewer	In 2D Viewer mode operator can review
original axial images as acquired by the
scanner.	Yes	The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent.
MPR	Use the MPR mode to view three-plane
orthogonal images. In this mode, the
three shown planes can be easily	Yes	The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent.
			Traditional 510(k)
	correlated. Three orthogonal cut
planes are shown:
• Axial Orientation
• Coronal Orientation
• Sagittal Orientation		CT and Ingenuity
CT are similar.
The Algorithm
Principle, function
and workflow are
same.
Therefore,
substantially
equivalent.
3D(volume
mode)	The volume mode is used to display CT
scanner data in a full volume image. It
provides basic tools for image editing
and generation of cine movies.	Yes	Volume rendering
protocol of
Incisive CT and
Ingenuity CT are
similar. The
function and
workflow are
same.
Therefore,
substantially
equivalent.
Virtual
Endoscopy
(Endo)	The CT Endo viewer is a review function
that allows you to perform a general
flythrough of any suitable anatomical
structure that is filled with air or with
contrast material, including general
vessels, cardiac vessels, the bronchus,
and the colon.	Yes	VE rendering
protocol of
Incisive CT and
Ingenuity CT are
similar. The
function and
workflow are
same.
Therefore,
substantially
equivalent.
Filming	The Filming application is used for
viewing, rearranging, windowing and
zooming images prior to sending them to
be printed.	Yes	Filming's basic
function like
display setting,
layout tools, and
image editing
tools, print
management of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent.
Image matrix	1024 * 1024	Yes	Both are 1024 *

Therefore,
substantially
equivalent. |
| | | | Traditional 510(k) |
| O-MAR | O-MAR stands for orthopedic metal
artifact reduction. This post processing
capability reduces metal induced artifacts
and is directed for large orthopedics
metals that cause photon starvation of
the rays that pass through the metal
object. | Yes | The Algorithm
Principle and
workflow of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent. |
| Dose
Modulation | Dose-Modulation is a scanner function
which modulates the tube current in two
ways (angular and longitudinal
modulation) simultaneously. | Yes | The function and
workflow of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent. |
| iPlanning | iPlanning can automatically adjust the
scan range of subsequent Axial or
Helical scan series, based on the
Surview Image. It enables the system to
automatically recognize the Head, Lung,
Lumbar Disc, Heart, Cervical Spine,
Liver, Pelvis, Caput femoris. The Head,
Cervical Spine and Lumbar Disc
recognition are based on lateral Surview,
the Heart recognition is based on dual
Surview, and the Lung and the other
parts recognition is based on frontal
Surview. | Manual | iPlanning is a
workflow
improvement to
assist user to
place the plan
box.
Safety and
effectiveness are
not affected.
Therefore,
demonstrating
Substantial
equivalence. |
| On line MPR | Use the on line MPR mode to view three-
plane orthogonal images. In this mode,
the three shown planes can be easily
correlated. | Yes | Ingenuity CT can
generate sagittal
and coronal
results and
support tilt and
trim. Incisive CT
can generate
sagittal and
coronal results
without trim and
tilt. The other
functions and
workflow are
same.
Therefore,
substantially
equivalent. |
| iBatch | iBatch application enables the system to
assist the user to identify the lumbar disk | Manual Batch | iBatch is a
workflow feature |
| | | | Traditional 510(k) |
| | space automatically and creating a batch
based on the protocol selected. | | to improve
productivity with
spine scan.
Safety and
effectiveness are
not affected.
Therefore,
demonstrating
substantial
equivalence. |
| Bolus Tracking | The Bolus tracking function maximizes
the efficiency of CT scans that are
enhanced through the use of a contrast
agent. This is done by preceding the
Clinical scan with Locator and Tracker
scans. | Yes | Post Threshold
Delay is longer
than Ingenuity
CT. The function
and workflow of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent. |
| SAS(Spiral Auto
Start) | This feature enable the usage of the
injector scan trigger. | Yes | The Incisive CT
could only trigger
inject manually in
SAS. The other
functions and
workflow of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent. |
| Worklist | The Worklist displays patient information
provided by the HIS/RIS. | Yes | The user interface
appearance of
Incisive CT and
Ingenuity CT are
similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent. |
| MPPS | If the patient is from the Worklist and the
MPPS function is enabled, feedback
regarding the study status of the patient
can be sent to the hospital HIS/RIS. | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function and |
| | | | Traditional 510(k) |
| | | | workflow are
same.
Therefore,
substantially
equivalent. |
| Reporting | The Reporting package allows you to
create customized reports using pre-
formatted templates.
A template is a specially designed
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. | Yes | The format of
exported report
are similar,
Incisive CT do not
support PDF
format. The other
functions and
workflow of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent. |
| CCT(Continuou
s CT) | Continuous CT (CCT) is a scanning
mode that allows the physician to
perform extended, low-dose scans while
performing a biopsy.
The resulting images display on a remote
monitor in the scan room, providing
visual feedback during the biopsy. | Yes | Incisive CT does
not support
Volume display.
The other
functions and
workflow of
Incisive CT and
Ingenuity CT are
same.
Therefore,
substantially
equivalent. |
| Brain Perfusion | Brain Perfusion is a blood flow imaging
application that analyzes the uptake of
injected contrast in order to determine
perfusion-related information about one
or more regions of interest. | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar,
the principle and
mechanism are
same.
Both provide the
same brain
perfusion analysis
parameters.
Therefore,
substantially
equivalent. |
| Dental (Dental
planning) | Dental application uses to create true-
size (life size) film images of the
mandible and maxilla for assisting oral
surgeons in planning implantation of
prostheses. Using a special dental | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar. |
| | | | Traditional 510(k) |
| | planning procedure, and the images will
be created from this scan which can be
input into the Dental planning application. | | The function and
workflow are
same.
Therefore,
substantially
equivalent. |
| iDose4 | iDose4 is an iterative reconstruction
technique that improves image quality
through artifact prevention and increased
spatial resolution at low dose. | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent. |
| Helical
Retrospective
Tagging | Helical retrospective cardiac scanning
enables the system to acquire a volume
of data while the patient's ECG is
recorded. The acquired data is tagged
and reconstructed retrospectively at any
desired phase of the cardiac cycle. | Yes | The ECG viewer
user interface of
Incisive CT and
Ingenuity CT are
similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent. |
| Axial
Prospective
Gating
calcium scoring | Axial prospective gating uses an external
ECG gating system to synchronize
individual axial scans with the patient's
heartbeat. The ECG-triggered scans
significantly minimize heart-motion
artifacts. | Yes | The ECG viewer
user interface of
Incisive CT and
Ingenuity CT are
similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent. |
| Step & Shoot | Step & Shoot Cardiac provides high
quality CT images of the coronary
arteries and heart anatomy at very low
radiation dose levels. During Step &
Shoot Cardiac, X-rays are generated
only during the cardiac phase of interest. | Yes | The ECG viewer
user interface of
Incisive CT and
Ingenuity CT are
similar. Incisive
CT does not
support
arrhythmia
handling in Step
& Shoot scan
mode. |
| | | | Traditional 510(k) |
| | | | The function and workflow are same.
Therefore, substantially equivalent. |
| CCS(Cardiac calcium scoring) | The Cardiac Calcium Scoring application is used to quantify the buildup of calcium plaque on the walls of the patient's coronary arteries and other relevant locations. The potential calcifications are highlighted by the application during launch. | Yes | The user interface layout of Incisive CT and Ingenuity CT are similar.
The function and workflow are same.
Therefore, substantially equivalent. |

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT

Section 5-510(k) Summary
Page 8 of 16

11

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12

Image /page/12/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT

13

Image /page/13/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.

Philips Healthcare (Suzhou) Co., Ltd.

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT

Section 5-510(k) Summary
Page 11 of 16

14

Philips Healthcare (Suzhou) Co., Ltd. Traditional 510(k)

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd.

Section 5-510(k) Summary
Page 12 of 16

15

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Philips Healthcare (Suzhou) Co., Ltd. : = :

Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT

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Supplementary Imaging Features Comparison
Proposed
Incisive CT
Features	Feature description	Reference
Predicate Device
PHILIPS MX 16
SLICE (K091195)	Conclusion
(Function/ User
interface/
Workflow)
CTC(CT
Colonoscopy)	CT Colonoscopy (CTC) application enables
fast and easy visualization of colon scans,
using acquired CT images.	Yes	The user interface
of Incisive CT and
Ingenuity CT are
similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent.
VA(Vessel
Analysis)	Vessel Analysis (VA) offers a set of tools for
general vascular analysis. With VA the user
can easily remove bone, and extract vessels.
User also can perform measurements such
as intraluminal diameter, cross-sectional
lumen area, length.	Yes	The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent.
			Traditional 510(k)
equivalent.
LNA(Lung
Nodule
Analysis)	The Lung Nodule Analysis (LNA) application
assists the radiologist with the detection and
quantification of pulmonary nodules and
lesions.	Yes	The user interface
of Incisive CT and
Ingenuity CT are
similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent.
Proposed
Incisive CT
Features	Feature description	Reference
Predicate Device
IntelliSpace
Portal
Platform(K16202

| Conclusion
(Function/ User
interface/
Workflow) |
| CAA(Cardiac
Artery
Analysis) | The Coronary Artery Analysis provides
viewing and measuring tools that allow you to
perform dimensional and quantitative
measurements of the coronary arteries to
help you identify and examine the patient
study for stenosis. | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
Both provide an
analysis of
cardiac coronary
artery.
The workflow are
same.
Therefore,
substantially
equivalent. |
| CFA(Cardiac
Function
Analysis) | Cardiac Function Analysis (CFA) application
is used to assess the state of the left
ventricle (LV) and to analyze functional heart
data. | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function and
workflow are
same.
Therefore,
substantially
equivalent. |
| Proposed
Incisive CT
Features | Feature description | Reference
Predicate Device
BRILLIANCE
DUAL ENERGY
OPTION
(K090462) | Conclusion
(Function/ User
interface/
Workflow) |
| DE(Dual
Energy) | Spin / Spin scan mode
Dual energy Viewer is an application for
review and analysis of CT dual-energy
scans. User need to load CT dual-energy
scan data which is two series with similar KV.
It provides registration function and can
generate different weighted KV images. User
can use the tools to separate materials. | Yes | The user interface
layout of Incisive
CT and Ingenuity
CT are similar.
The function,
Algorithm
Principle and
workflow are
same.
Therefore,
substantially
equivalent. |

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18

| Substantial
Equivalence
Conclusion: | The design, intended use, technology and principal technological
components (Tube, Generator, Detector) of the proposed Philips
Incisive CT substantially equivalent to the currently marketed
primary predicate device Philips Ingenuity CT (K160743,
08/08/2016).Based on the information provided above, the
proposed Philips Incisive CT does not raise different questions
of safety and effectiveness compare to the currently marketed
primary predicate device Philips Ingenuity CT (K160743,
08/08/2016). The proposed Philips Incisive CT is identical to the
primary predicate device Philips Ingenuity CT (K160743,
08/08/2016), and therefore is considered substantially equivalent.

Additionally, substantial equivalence was demonstrated with non-
clinical performance (verification and validation) tests, which
complied with the requirements specified in the international and
FDA-recognized consensus standards.

The results of these tests demonstrate that the proposed Philips
Incisive CT meet the acceptance criteria and is adequate for its
intended use. |

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