Who is the manufacturer of Philips Incisive CT?

Philips Healthcare (Suzhou) Co., Ltd. filed the 510(k) submission for Philips Incisive CT (K212441).

What is the FDA product code for Philips Incisive CT?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Philips Incisive CT?

510(k) clearance (submission type: Traditional).

Does Philips Incisive CT use AI or machine learning?

Yes. Philips Incisive CT (K212441) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Philips Incisive CT?

Philips Ingenuity CT (K160743); Philips Incisive CT (K180015).

Who can help prepare an FDA 510(k) submission like Philips Incisive CT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Philips Incisive CT get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Philips Incisive CT

K212441 · Philips Healthcare (Suzhou) Co., Ltd. · JAK · Apr 27, 2022 · Radiology

Device Facts

Record ID	K212441
Device Name	Philips Incisive CT
Applicant	Philips Healthcare (Suzhou) Co., Ltd.
Product Code	JAK · Radiology
Decision Date	Apr 27, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended 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.

Device Story

Philips Incisive CT is a whole-body computed tomography system; utilizes continuously rotating x-ray tube, detector array, and gantry to acquire transmission data. System reconstructs data into cross-sectional images; includes signal analysis, display equipment, and patient support couch. Operated by clinicians in diagnostic imaging environments. Features include iterative reconstruction (iDose4), cardiac gating, and various clinical applications (e.g., Brain Perfusion, Lung Nodule Analysis, Vessel Analysis). Output consists of diagnostic images and quantitative data for clinical decision-making. Benefits include improved image quality, artifact reduction (O-MAR), and workflow efficiency. System supports advanced features like Precise Image (deep learning noise reduction), Precise Cardiac (motion compensation), and Precise Position (automated patient positioning).

Clinical Evidence

No clinical study required. Substantial equivalence established through non-clinical performance data, design verification, and design validation testing. System verification conducted against system requirement specifications (SRS) using manual/automated tests and analysis. Validation included workflow assessment and compliance with international consensus standards (IEC 60601 series, ISO 14971).

Technological Characteristics

Whole-body CT system with 72cm bore, 50cm scan FOV, 64/128 slice capability. Components: rotating x-ray tube, generator, detector array, gantry, patient couch, and console. Connectivity: DICOM compliant. Software: iterative reconstruction (iDose4), deep learning-based reconstruction (Precise Image), and automated positioning (Precise Position). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, IEC 62304, ISO 14971, NEMA XR 25/28/29.

Indications for Use

Indicated for head, whole body, cardiac, and vascular CT imaging in patients of all ages. Includes low-dose CT lung cancer screening for early detection of lung nodules in accordance with established professional or governmental protocols.

Regulatory Classification

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.

Predicate Devices

Philips Ingenuity CT (K160743)
Philips Incisive CT (K180015)

Reference Devices

Precise Image (K210760)
Precise Cardiac (K203020)
Precise Position (K203514)

Related Devices

K180015 — Philips Incisive CT · Philips Healthcare (Suzhou) Co., Ltd. · Mar 20, 2018
K250648 — Philips iCT CT system · Philips Medical Systems Nederland B.V. · Jun 27, 2025
K160743 — Philips Ingenuity CT · Philips Medical Systems (Cleveland), Inc. · Aug 8, 2016
K223311 — Philips CT 3500 · Philips Healthcare (Suzhou) Co., Ltd. · Dec 22, 2022
K131773 — BRILLIANCE ICT · Philips Healthcare (Cleveland) · Sep 24, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ April 27, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. 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) K212441 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) | <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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 [PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov) "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text 'K212441' in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, making the text easily readable. Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text. # 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 | {4}------------------------------------------------ Image /page/4/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. | 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 | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The font is sans-serif and appears to be a standard typeface. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill the majority of the frame. The background is plain white, which makes the blue text stand out. The font appears to be sans-serif. {7}------------------------------------------------ Image /page/7/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 the only element in the image and it is centered. 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. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and are a bright blue color. The word is centered and takes up most of the frame. | | 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. | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is white, which makes the blue letters stand out. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface. | 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. | {11}------------------------------------------------ Image /page/11/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. {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. The background is white. {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. The background is white. 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 {14}------------------------------------------------ Image /page/14/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. | 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. | {15}------------------------------------------------ Image /page/15/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 horizontally oriented and centered in the image. | 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. |