Who is the manufacturer of Vitrea CT Colon Analysis?

Vital Images, Inc. filed the 510(k) submission for Vitrea CT Colon Analysis (K160150).

What is the FDA product code for Vitrea CT Colon Analysis?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Vitrea CT Colon Analysis?

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

What are the predicate devices for Vitrea CT Colon Analysis?

VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) (K052632).

Who can help prepare an FDA 510(k) submission like Vitrea CT Colon Analysis?

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.

Vitrea CT Colon Analysis

K160150 · Vital Images, Inc. · LLZ · Mar 16, 2016 · Radiology

Device Facts

Record ID	K160150
Device Name	Vitrea CT Colon Analysis
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Mar 16, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.

Device Story

Vitrea CT Colon Analysis is radiological image processing software used by radiologists, clinicians, or technologists to visualize and analyze colon CT scans. It inputs DICOM CT data and provides tools including auto-segmentation, multi-planar reformatting, 3D volume rendering, and endoluminal fly-through. A key feature is Electronic Bowel Cleansing, which electronically removes residual fecal material tagged with a contrast agent to improve visualization of the colon wall. The software operates on the Vitrea platform; it does not provide automated diagnosis but assists the physician in identifying polyps, masses, and lesions. Output is displayed on a workstation for clinical review, supporting decision-making by providing clearer views of potential pathologies. It benefits patients by facilitating more thorough colon examinations, particularly when full bowel evacuation is incomplete.

Clinical Evidence

No clinical studies were required. Safety and effectiveness were demonstrated through non-clinical bench testing, including software verification, validation, phantom testing, and simulated usability testing by experienced professionals. Performance metrics for the Electronic Bowel Cleansing feature were evaluated using real patient data and phantoms to ensure accuracy in polyp diameter measurement and segmentation.

Technological Characteristics

Radiological image processing software; DICOM-compliant; operates on the Vitrea platform. Features include auto-segmentation, 3D volume rendering, and Electronic Bowel Cleansing (tagging/subtraction). Complies with DICOM, IEC 62304 (software life cycle), and ISO 14971 (risk management) standards. Deployment is via the Vitrea platform.

Indications for Use

Indicated for adult patients with suspected colon pathologies (e.g., polyps, masses, lesions) to aid radiologists, clinicians, or technologists in screening and assessment.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) (K052632)

Reference Devices

syngo.CT Colonography (K140920)

Related Devices

K023943 — CT COLONOGRAPHY · Ge Medical Systems, Inc. · May 6, 2003
K123566 — SYNAPSE 3D COLON ANALYSIS · Fujifilm Medical Systems U.S.A, Inc. · Jan 22, 2013
K040126 — VIATRONIX V3D COLON, REVISION 1.3 · Viatronix, Inc. · Apr 19, 2004
K041270 — CT COLONOGRAPHY II · General Electric Medical Systems · May 27, 2004
K140920 — SYNGO.CT COLONOGRAPHY · Siemens Medical Solutions USA, Inc. · Dec 3, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned inside a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 16, 2016 Vital Images, Inc. % Ms. Alexis Erazo Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414 Re: K160150 Trade/Device Name: Vitrea CT Colon Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 20, 2016 Received: January 21, 2016 Dear Ms. Erazo: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 {1}------------------------------------------------ or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Michael D'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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160150 Device Name Vitrea CT Colon Analysis Indications for Use (Describe) The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL". The logo appears to be for a medical company. # 510K Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c). | Basis for the Submission: | Vital Images, Inc. hereby submits this Traditional 510(k) to provide a notification submission for proposed software changes in the already 510(k) cleared K052632 VITREA2 Version 3.8 (CT Colonography Application). | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN, 55343-4414 | | Establishment Registration: | 2134213 | | Contact Person: | Alexis Erazo Regulatory Affairs Specialist Phone : 952-487-9774 Fax: 952—487—9510 E-mail: aerazo@vitalimages.com | | 510(k) Type: | Traditional | | Summary Date: | January 20, 2016 | | Device Trade Name: | Vitrea® CT Colon Analysis | | Device Common Name/ Regulatory Description: | Radiological Image Processing Software | | Device Classification Name: | System, Image Processing, Radiological | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | LLZ | | Regulatory Classification: | Class II | | Device Panel: | Radiology | # Predicate Device(s): | Predicate Device | Manufacturer | FDA 510(k) Number | |------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------| | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) | Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343 | K052632 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The letters in the word "VITAL" are all capitalized, and the dot above the "i" is a circle. # Reference Device(s): | Reference Device | Manufacturer | FDA 510(k) Number | |-----------------------|--------------------------------------------------------------------------------------|-------------------| | syngo.CT Colonography | Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 | K140920 | ## Device Description: Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features: - . Auto-seqmentation of the colon - . Segmentation editing - . Axial imaging, multi-planar reformatting and 3D views - . Manual and automatic endoluminal fly-through of the colon - . Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode - MPR eye placement to adjust view direction down lumen - . Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through - . Dual Volume Viewer window format for side-by-side comparison of prone and supine studies - Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close - SPACE BAR to step through images containing arrows - Prone/supine registration . - . Polyp Probe tool to select and characterize polyps - Polyp assessment using the C-RADS guidelines - . Fly-through image batches and digital movies - Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template - . Fly-through keyboard shortcuts - . Automatic fluid/stool tagging and subtraction Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care. ### Intended Use / Indications for Use: The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, flythrough, simultaneous display of prone and supine images, and transparent wall view. 048 Updated 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in black, with the "i" having a dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red. The text is centered and the font is sans-serif. ## Intended for Disease / Condition / Patient Population: The software provides trained Radiologists, Clinicians or Technologist with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their screening and assessment of adult patients with suspected colon pathologies (i.e. suspicious polyps, masses, and lesions). ## Rationale for Additions and Enhancements to CT Colonography Software: Vitrea users, require an intuitive, accurate, and efficient application to review, investigate, and problem solve their colonography exams in order to provide information for the referring clinicians. Many patients are unable to complete full evacuation of fecal material and residual liquids in the colon, which can obscure potential lesions and pathology. Vital customers have repeatedly requested to have functionality to electronically remove this residual material from the colon in order to fully evaluate the colon for any abnormalities. When viewing the colon in either 2D or 3D it is very important to see all aspects of the colon, so Vital is introducing "Bowel Cleansing" as a means to remove any residual materials that may inhibit a reader from fully visualizing all aspects of the colon interior. Vital customers will now be able to electronically remove any residual fecal material that has been tagged with a tagging agent. # Substantial Equivalence Comparison: | | Subject Device | Predicate Device | | |---------------------|----------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------| | Characteristic | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | Same | | Regulatory Number | 892.2050 | 892.2050 | Same | | Product Code | LLZ | LLZ | Same | | Classification | Class II | Class II | Same | | Review Panel | Radiology | Radiology | Same | | Decision Date | Under Review | December 15, 2005 | Predicate and Reference devices are cleared | #### Regulatory Comparison: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller font size. # Indications for Use Comparison with Predicate Device: | | Subject Device | Predicate Device | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Criteria | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | Indications for Use | The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view. | The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view. | Same | | Intended Users | Radiologists, Clinicians or Technologist | Radiologists, Clinicians or Technologist | Same | | Patient Population | Adult patients with suspected colon pathologies | Patients with suspected colon pathologies | Similar | | | Subject Device | Predicate Device | | | Criteria/Feature | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | Modality | | | | | CT | Yes | Yes | Same | | Data Loading | | | | | DICOM | Yes | Yes | Same | | Ability to load one or two series of chest CT exam | Yes | Yes | Same | | Data Viewing Support | | | | | 2D Imaging Real-time window level, zoom and pan | Yes | Yes | Same | | 3D Imaging Volume rendering with window-level, rotate, zoom an pan | Yes | Yes | Same | | Features and Capabilities | | | | | 3D Measurements Manual contour volumes and diameter | Yes | Yes | Same | | 2D Measurements Ruler and ROI tools with statistics | Yes | Yes | Same | | 3D/Axial Review | Yes | Yes | Same | | Dual Volume Viewer | Yes | Yes | Same | | Endoluminal Fly- Through | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Criteria/Feature | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | Target-based navigation for examining a POI | Yes | Yes | Same | | Eye-based navigation for performing fly- throughs | Yes | Yes | Same | | Assisted navigation | Yes | Yes | Same | | Reverse view mode | Yes | Yes | Same | | Fly-through images batches and digital movies | Yes | Yes | Same | | Viewer auto rotation to keep gravity | Yes | Yes | Same | | MPR eye placement to adjust view direction down lumen | Yes | Yes | Same | | Multi-planner reformatting Any user defined linear plane, MIP and average | Yes | Yes | Same | | Auto-cine | Yes | Yes | Same | | Save workflow Restorable state from user snapshots, including multiple volume sessions | Yes | Yes | Same | | Printing Printing to standard windows printers | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Criteria/Feature | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | Ease of use Visualization presets for typical image review procedures Click-Drag-Click ruler interaction When In fly Though, click on tissue rotates to look at the crosshair "decoupled" eye and crosshair | Yes | Yes | Same | | Viewers Ability to not update MPRs while flying, only updates when you stop flying Lock MPR Cine Displays x, y, z, value for crosshair position to lower right of viewers | Yes | Yes | Same | | Viewing capacities MPR viewing of candidates Endoluminal viewing of candidates with | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Criteria/Feature | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | viewing" technology | | | | | Hardware Requirements | Identical to the Vitrea® Platform | Identical to the Vitrea® Platform | Same | | Software Requirements | Identical to the Vitrea® Platform | Identical to the Vitrea® Platform | Same | | Performance Testing | | | | | Nonclinical Testing Safety and Performance Standards | Yes. The subject device is designed to fulfill the requirements of the following standards DICOM, IEC 62304, and ISO 14971. | Yes. The CT Colonography software within VITREA2, Version 3.8 was designed to fulfill the requirements of the following standards DICOM, IEC 62304, and ISO 14971. | Same. | | Software Verification and Validation | Yes. Vital has completed and provided Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 | Yes. The K052632 Submission contained Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 | Same. Please reference Attachments_03 5-043 for more details. | | Clinical Testing | Yes. Clinical performance tests were conducted to demonstrate performance, safety, and effectiveness of the CT Colon Analysis Electronic Bowel Cleansing feature using datasets based on | Yes. Clinical performance tests were conducted to demonstrate performance, safety, and effectiveness of the CT Colonography software within VITREA2, Version 3.8. | Same. Please reference Attachment_036 VLC-08319 A Colon Electronic Bowel Cleansing Algorithm Verification and Validation and Attachment_039 | | | Subject Device | Predicate Device | | | Criteria/Feature | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | | real patient data and phantoms. | | VLC-08836 A Vitrea CT Colon EBC Verification and Validation Summary for more details. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle. # Similarities in Technology with Predicate Device: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of the word "VITAL" are black, and the dot on the "i" is white. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo is simple and professional, likely representing a company or organization. # Differences in Technology with the Predicate Device: | Criteria | Subject Device | Predicate Device | | |-------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Vitrea® CT Colon Analysis Software | VITREA2, Version 3.8 Medical Image Processing System (CT Colonography) K052632 | Comparison | | Electronic Bowel Cleansing | Yes | No | Predicate device does not contain the automatic fluid/stool tagging and subtraction feature. The added feature does not affect the intended use, indications for use, or fundamental scientific technology of the already cleared CT Colonography K052632. | ## Similarities in Technology with the Reference Device: The Electronic Bowel Cleansing enhancement features, subject of this 510(k) Submission, are highlighted in yellow color. | Feature/Criteria | Subject Device | Reference Device | Comparison | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modality | Vitrea® CT Colon Analysis Software | syngo.CT Colonography (K140920) | | | CT | Yes | Yes | Same | | | Subject Device | Reference Device | Comparison | | Feature/Criteria | Vitrea® CT Colon Analysis Software | syngo.CT Colonography (K140920) | | | Data Loading | | | | | DICOM | Yes | Yes | Same…