Who is the manufacturer of Philips Incisive CT?

Philips Healthcare (Suzhou) Co., Ltd. filed the 510(k) submission for Philips Incisive CT (K180015).

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).

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.

Philips Incisive CT

Q: What are the predicate devices for Philips Incisive CT?

Philips Ingenuity CT (K160743).

K180015 · Philips Healthcare (Suzhou) Co., Ltd. · JAK · Mar 20, 2018 · Radiology

Device Facts

Record ID	K180015
Device Name	Philips Incisive CT
Applicant	Philips Healthcare (Suzhou) Co., Ltd.
Product Code	JAK · Radiology
Decision Date	Mar 20, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	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

Incisive CT is a whole-body multi-slice CT system; utilizes continuously rotating x-ray tube, detectors, and gantry to acquire x-ray transmission data; computer reconstructs data into cross-sectional images. Operated by clinicians in clinical settings; includes patient support couch and console for user interface. Features include 2D/3D viewing, MPR, O-MAR (metal artifact reduction), dose modulation, and various clinical applications (cardiac, vascular, lung nodule analysis). iPlanning automatically adjusts scan range based on Surview images. Output is diagnostic quality images for clinical decision-making; assists in diagnosis and lung cancer screening. Benefits include improved workflow and diagnostic capabilities.

Clinical Evidence

No clinical study required. Substantial equivalence established via verification/validation testing and comparison of clinical/phantom sample images to demonstrate diagnostic quality.

Technological Characteristics

Whole-body CT system; 72cm bore; 50cm FOV; 64/128 slice capability. Components: Gantry (stator, rotor, X-ray tube, generator, detector array), patient support, console. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, NEMA XR 25, NEMA XR 28, NEMA XR 29. Software lifecycle per IEC 62304. Iterative reconstruction (iDose4).

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 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)

Reference Devices

Philips MX 16 SLICE (K091195)
IntelliSpace Portal Platform (K162025)
BRILLIANCE DUAL ENERGY OPTION (K090462)

Related Devices

K160743 — Philips Ingenuity CT · Philips Medical Systems (Cleveland), Inc. · Aug 8, 2016
K212441 — Philips Incisive CT · Philips Healthcare (Suzhou) Co., Ltd. · Apr 27, 2022
K200498 — SCENARIA View · Hitachi Healthcare Americas · Jul 17, 2020
K190841 — SCENARIA View · Hitachi Healthcare Americas · Sep 13, 2019
K162838 — Philips iCT CT System · Philips Medical Systems (Cleveland), Inc. · Apr 7, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and consists of a stylized emblem. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="16" width="16"> <polygon points="1 1, 15 1, 15 15, 1 15" style="fill:none;stroke:black;stroke-width:2"></polygon> <polyline points="3 8, 7 13, 13 3" style="fill:none;stroke:black;stroke-width:3"></polyline> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="16" width="16"> <polygon points="1 1, 15 1, 15 15, 1 15" style="fill:none;stroke:black;stroke-width:2"></polygon> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff *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." FORM FDA 3881 (7/17) {3}------------------------------------------------ Image /page/3/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 is centered. #### 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 {4}------------------------------------------------ Image /page/4/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. {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. {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, providing a clear contrast to the blue text. | 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 * 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 …