(266 days)
Not Found
Yes
The summary explicitly states "Mentions AI, DNN, or ML: Yes".
No
The device is described as being used for diagnostic imaging and screening to produce images of the body, which are diagnostic purposes, not therapeutic.
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*." This directly indicates its diagnostic purpose.
No
The device description explicitly details hardware components such as a gantry, x-ray tube, detectors, patient support, and console, indicating it is a physical medical device system, not software-only.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Incisive CT is a Computed Tomography X-Ray System. Its function is to produce images of the head and body using X-rays and computer reconstruction. It does not perform tests on biological samples.
- Intended Use: The intended use is for diagnostic imaging and low dose CT lung cancer screening, which involves generating images for visual interpretation by a medical professional, not analyzing biological samples.
Therefore, the Incisive CT falls under the category of medical imaging devices, not In Vitro Diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The query for "Control Plan Authorized (PCCP) and relevant text" returned "Not Found".
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
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
Yes
Input Imaging Modality
Computed Tomography (CT) X-Ray
Anatomical Site
head, whole body, cardiac and vascular
Indicated Patient Age Range
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.
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. The systems pass the design verification, design validation and consensus standards test as nonclinical tests. The system verification is conducted against the system requirement specifications (SRS). System verification activities demonstrate the system meet the established system design input requirements. System requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Non-Clinical design validation testing covered the intended use and commercial claims. Validation testing included workflow validation.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
April 27, 2022
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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
Re: K212441
Trade/Device Name: Philips Incisive CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: March 16, 2022 Received: March 16, 2022
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92(c)]
| Date Prepared: | July 30, 2021 |
|---|---|
| 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 | Erhong Wang |
| Senior Manager Regulatory Affairs | |
| Phone: +86-512-67336804 | |
| E-mail: ErHong.WANG@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 | |
| Secondary Predicate Device: | Trade name: Philips Incisive CT |
| Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. | |
| 510(k) Clearance: K180015 | |
| Classification Regulation: 21CFR 892.1750 | |
| Classification name: Computed tomography x-ray system | |
| Classification Panel: Radiology | |
| Device class: Class II | |
| Product Code: JAK |
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| 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). | Traditional 510k |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | 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. | |
| | Traditional 510(k) | |
| 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. | |
| 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: | |
| | • 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 60601-2-44:2016 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 Medical device software -- Software life
cycle processes
FDA/CDRH recognition number 13-79 | |
| | • IEC 62366-1:2015, Medical devices -- Part 1: Application
of usability engineering to medical devices
FDA/CDRH recognition number 5-114 | |
| | • ISO14971 Medical devices - Application of risk
management to medical devices (Ed. 3.0, 2019)
FDA/CDRH recognition number 5-125 | |
| | • NEMA XR 25-2010 Computed Tomography Dose Check
FDA/CDRH recognition number 12-225 | |
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6
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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. The systems pass the design verification, design validation and consensus standards test as nonclinical tests. The system verification is conducted against the system requirement specifications (SRS). System verification activities demonstrate the system meet the established system design input requirements. System requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Non-Clinical design validation testing covered the intended use and commercial claims. Validation testing included workflow validation.
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| 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. | |
|---|---|
| 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. |
Substantial Equivalence
| Scan characteristics Comparison | |||
|---|---|---|---|
| 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 | |||
| mode: 13 lp/cm | High resolution mode:16 lp/cm | ||
| Standard resolution mode: | |||
| 13 lp/cm | Identical. | ||
| Therefore, substantially | |||
| equivalent. | |||
| 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. | |||
| Display | 1920 * 1080 | 1024 * 1280 | The proposed Philips Incisive CT provide higher resolution than Ingenuity CT. |
| Safety and effectiveness are not affected. | |||
| Therefore, demonstrating substantial equivalence. |
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10
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| Host
Infrastructure | Windows 10 | Windows 7 | Same supplier, same
technology and similar
function.
Therefore, substantially
equivalent. |
|-------------------------------------|----------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication | Compliance with
DICOM | Compliance with DICOM | Identical.
Therefore, substantially
equivalent. |
| Dose Reporting
and
Management | Compliance with NEMA
XR25 , XR28 and XR29 | Compliance with NEMA
XR25 and XR29 | Compliance with more
NEMA standard.
Safety and
effectiveness are not
affected.
Therefore,
demonstrating
substantial
equivalence. |
| Imaging features Comparison | |||
|---|---|---|---|
| Incisive CT | |||
| Features | |||
| Name | Feature description | Secondary | |
| Predicate | |||
| Device Philips | |||
| Incisive | |||
| CT(K180015) | Conclusion | ||
| (Function/ User | |||
| interface/ | |||
| Workflow) | |||
| 2D Viewer | In 2D Viewer mode operator can review | ||
| original axial images as acquired by the | |||
| scanner. | Yes | Identical. | |
| MPR | Use the MPR mode to view three-plane | ||
| orthogonal images. In this mode, the three | |||
| shown planes can be easily correlated. | |||
| Three orthogonal cut | |||
| planes are shown: | |||
| • Axial Orientation | |||
| • Coronal Orientation | |||
| • Sagittal Orientation | Yes | Identical. | |
| 3D(volume | |||
| mode) | The volume mode is used to display CT | ||
| scanner data in a full volume image. It | Yes | Identical. | |
| provides basic tools for image editing and | |||
| generation of cine movies. | |||
| 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 | Identical. | |
| Filming | The Filming application is used for viewing, | ||
| rearranging, windowing and zooming | |||
| images prior to sending them to be printed. | Yes | Identical. | |
| Image matrix | 1024 * 1024 | Yes | Identical. |
| 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 | Identical. | |
| Dose | |||
| Modulation | Dose-Modulation is a scanner function | ||
| which modulates the tube current in two | |||
| ways (angular and longitudinal modulation) | |||
| simultaneously. | Yes | Identical. | |
| Scan | |||
| Preparation | iPlanning / Manual | Yes | Identical. |
| 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 | Identical. | |
| Control | |||
| Panel | iStation (Touch Panel) | Yes | Identical. |
| iBatch | iBatch application enables the system to | ||
| assist the user to identify the lumbar disk | |||
| space automatically and creating a batch | |||
| based on the protocol selected. | Yes | Identical. | |
| 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 | Identical. | |
| SAS(Spiral | |||
| Auto Start) | This feature enable the usage of the injector | ||
| scan trigger. | Yes | Identical. | |
| Worklist | The Worklist displays patient information | ||
| provided by the HIS/RIS. | Yes | Identical. | |
| 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 | Identical. | |
| Reporting | Traditional 510(k) | ||
| 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 | Identical. |
| CCT(Continuous 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 | Identical. |
| 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 | Identical. |
| 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 planning procedure, and the images will be created from this scan which can be input into the Dental planning application. | Yes | Identical. |
| iDose4 | iDose4 is an iterative reconstruction technique that improves image quality through artifact prevention and increased spatial resolution at low dose. | Yes | Identical. |
| 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 | Identical. |
| 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 | Identical. |
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Traditional 510(k) Step & Shoot Cardiac provides high quality Step & Yes Identical. CT images of the coronary arteries and Shoot heart anatomy at very low radiation dose levels. During Step & Shoot Cardiac, X-rays are generated only during the cardiac phase of interest. The Cardiac Calcium Scoring application is CCS(Cardia Yes ldentical. used to quantify the buildup of calcium c calcium plaque on the walls of the patient's coronary scoring) arteries and other relevant locations. The potential calcifications are highlighted by the application during launch. Precise image reconstruction is a recon Precise No Different: mode where the system uses a image safety and trained deep learning neural network to effectiveness generate noise reduction images refer to and improve low contrast detectability K210760 for with reduced dose compared with Precise Image standard FBP recon mode. Precise Cardiac is a reconstruction Different: Precise No technique with the potential to cardiac safety and provide compensation for cardiac effectiveness refer to motion. K203020 for Precise Cardiac Precise Position is a camera based Precise No Different: workflow designed to assist with position Safety and positioning the patient automatically effectiveness from console or OnPlan, it can: refer to • automatically select patient orientation. K203514 for • automatically set vertical centering & Precise Position positioning of the patient to the Surview start and end positions. • support editing Surview start & end range and scan direction. In Precise Intervention viewer there are Precise No Different: Precise several tools, they will help intervention intervention is a you to navigate the needle safely during function that the intervention. support user to view the distance, angle between the injector and the object, system validation report proved that
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| Direct
results | Direct Result-With Direct Result the user
is able to choose a desired
result during scan planning phase and get
the result for diagnosis without
further intervention. | No | Different: Direct
result is
workflow
enhancement to
make user direct
get derived
image after
acquisition no
impact on
system safety
and effectiveness | there is no
impact on
system safety
and effectiveness |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Parallel
workflow | Parallel workflow
The system support Parallel workflow using
Dual monitor as below:
- main monitor: Patients, scan, service, "show
all" for scan planning, Help. - extend monitor: Completed, viewers, Analysis,
recon, filming, report | No | The Parallel
workflow of
Incisive CT is the
workflow
update, no
impact safety
and
effectiveness. | |
| Supplementary Imaging features Comparison | |||
|---|---|---|---|
| Incisive CT | |||
| Features | |||
| Name | Feature description | Secondary | |
| Predicate | |||
| Device Philips | |||
| Incisive | |||
| CT(K180015) | 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 | Identical. | |
| 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 | Identical. |
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| LNA(Lung
Nodule
Analysis) | The Lung Nodule Analysis (LNA)
application assists the radiologist with the
detection and quantification of pulmonary
nodules and lesions. | Yes | Identical. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|------------|
| 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 | Identical. |
| 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 | Identical. |
| 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 | Identical. |
| | 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, V&V and consensus standards 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. |