Who is the manufacturer of Vitrea, Version 7.0 Medical Image Processing Software?

Vital Images, Inc. filed the 510(k) submission for Vitrea, Version 7.0 Medical Image Processing Software (K150258).

What is the FDA product code for Vitrea, Version 7.0 Medical Image Processing Software?

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, Version 7.0 Medical Image Processing Software?

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

What are the predicate devices for Vitrea, Version 7.0 Medical Image Processing Software?

Vitrea, Medical Image Processing Software, Version 4.0 (K071331).

Who can help prepare an FDA 510(k) submission like Vitrea, Version 7.0 Medical Image Processing Software?

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, Version 7.0 Medical Image Processing Software

K150258 · Vital Images, Inc. · LLZ · Mar 5, 2015 · Radiology

Device Facts

Record ID	K150258
Device Name	Vitrea, Version 7.0 Medical Image Processing Software
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Mar 5, 2015
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography.

Device Story

Vitrea is a medical diagnostic system for multi-dimensional visualization, analysis, and communication of digital images. It retrieves DICOM data over a network, displays images via dedicated protocols, and allows clinicians to interactively manipulate, annotate, measure, and record 2D/3D views. The system supports multi-user, multi-modality departmental workflows. It includes a CPU-based rendering engine for virtual deployments and a VIMS component for external DICOM communication. Clinicians use the output for anatomical and pathological analysis to aid in clinical decision-making. The system is used in clinical environments by healthcare professionals.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation were performed to ensure requirements were met, including risk management, code reviews, and requirements traceability.

Technological Characteristics

Radiological image processing software (21 CFR 892.2050). Features CPU-based rendering engine, DICOM-compliant data management, and multi-user workstation support. Connectivity via DICOM and Web Services. Complies with NEMA PS 3.1-3.20 (DICOM), ISO 14971:2007 (Risk Management), and IEC 62304:2006 (Software Life Cycle).

Indications for Use

Indicated for processing, review, analysis, communication, and media interchange of multi-dimensional digital images from various imaging devices. Not for primary image interpretation in mammography. No specific patient population or contraindications defined.

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

Vitrea, Medical Image Processing Software, Version 4.0 (K071331)

Related Devices

K172855 — Vitrea Advanced Visualization, Version 7.6 · Vital Images, Inc. · Oct 5, 2017
K040305 — VITREA2 VERSION 3.5 · Vital Images, Inc. · Feb 24, 2004
K052632 — VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE · Vital Images, Inc. · Dec 15, 2005
K170167 — True 3D Viewer Software · Echopixel, Inc. · Mar 3, 2017
K072821 — VITREA 4DCT · Vital Images, Inc. · Feb 20, 2008

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 encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 5, 2015 Vital Images, Inc. % Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343 Re: K150258 Trade/Device Name: Vitrea®, Version 7.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 4, 2015 Received: February 5, 2015 Dear Parthiv Shah: 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. {1}------------------------------------------------ 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 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, Robert A Ochs Robert Ochs. Ph.D. Acting 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) # Device Name Vitrea®, Version 7.0 Medical Image Processing Software ### Indications for Use (Describe) Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image Interpretation in mammography. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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". ## 510(k) Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c) | Purpose of Submission: | Vital Images, Inc. hereby submits this special 510(k) to provide a notification submission for proposed software changes in the already 510(k) cleared Vitrea software (K071331). | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN, 55343-4414 | | Establishment Registration: | 2134213 | | Contact Person: | Parthiv Shah Sr. Regulatory Affairs Specialist Phone : 952-487-9574 Fax: 952-487-9510 E-mail: pshah@vitalimages.com | | 510(k) Type: | Special | | Summary Date: | February 3, 2015 | | Device Trade Name: | Vitrea, Medical Image Processing Software | | Other Device Trade Names: | Vitrea Enterprise Suite, VitreaCore, VitreaAdvanced, VitreaAdvanced fX, VitreaWorkstation, VitreaWorkstation fX, VitreaExtend | | Device Common Name: | Radiological Image Processing Software | | Device Classification Name: | System, Image Processing, Radiological | | Regulatory Description: | Picture Archiving and Communications System | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | LLZ | | Regulatory Classification: | Class II | | Device Panel: | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context. ### Predicate Device: | Predicate Device | Manufacturer | FDA 510(k) number | |-------------------------------------------------------------------------------------------|--------------------|-------------------| | Vitrea, Medical Image Processing Software, Version 4.0 (Legally Marketed Device) | Vital Images, Inc. | K071331 | ### Device Description: Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: - Retrieve image data over the network via DICOM ● - Display images that are automatically adapted to exam type via dedicated protocols ● - Select images for closer examination from a gallery of up to six 2D or 3D views - Interactively manipulate an image in real-time to visualize anatomy and pathology ● - Annotate, tag, measure, and record selected views - Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device - . Retrieve reports that are archived on a Web server ### Intended Use / Indications for Use: Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. ### Scope of Changes: Vital Images is replacing / updating some components of Vitrea platform to utilize enhancements in software technology for better performance of the Vitrea software. | # | Replaced Software Component (Version 7.0) | Rationale for Changes | |---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | 1 | Product Infrastructure It is a collection of non-clinical applications that work on top of the platform to provide common functions and assist with overall workflow. | Redesigned for better user experience and support for web-based applications. | | # | Replaced Software Component (Version 7.0) | Rationale for Changes | | | New Components: | | | | Vitrea Client (AppShell): Launches other applications and embeds the applications within a common window. | | | | Hosts product applications that allow the users to view the Study List and launch various applications with DICOM data. | | | | Study List: Displays the list of patient data received from DICOM modalities, associated evidence for patient studies, and available applications to load data into. | | | | 2 | | | | Enhanced features: | application integration. | | | Application Management: Application Management is a key feature of the platform, which is designed to let applications be installed, registered, and licensed independently of the platform. | | | | The AppManager component is also responsible for lifecycle management (startup and shutting down idle/abandoned sessions) for launched applications. | | | | User Management: User Management provides authentication and authorization, auditing, user preferences, roles & group management. These can be configured directly within the platform, or integrated to external user management systems such as Active Directory. | | | | Data Access: Data Access features include DICOM search, evidence management, temporary data management, UID generation, and session save/restore. | | | | Systems Management: Systems Management consists of system settings, configuring DICOM endpoints, installing licenses, and configuring network security settings. | | | # | Replaced Software Component (Version 7.0) | Rationale for Changes | | | Workflow: Workflow is an anticipatory processing feature which allows applications to register for and perform batch processing when new data arrives; for example extracting data from structure reports, generating alternate representations (e.g. MPR projections, bone removal), image analysis. | | | 3 | CPU-Based Rendering Engine A CPU-based rendering engine performs rendering using CPU only. It does not require a GPU card to be present on the system. In order to support deployments those do not have GPU hardware or do not have access to GPU hardware, such as virtual deployments, it is important to have a CPU-based rendering engine. New Component: We have introduced an additional CPU-based rendering engine. It is a software-based rendering engine used for rendering patient data in clinical applications. | Newly added rendering engine for CPU rendering support use for virtual deployments. | | 4 | DICOM Cache This component keeps a local copy of DICOM images received from PACS and/or modalities in order to provide fast access for user applications to enable a good user experience. New Components: Vitrea Information Management System (VIMS): The VIMS is the communicator to the world outside the Vitrea station. It connects to other systems via the DICOM standard. VIMS is a separate process running on the Vitrea station that is independent of the Vitrea application. Communication to and from VIMS is done via Web Services. The key features are DICOM receive (multi-byte data set support), DICOM Export, Volume building, and DICOM print. MINT: The Medical Imaging Network Transport (MINT) protocol is a server component for accessing DICOM data through web services. | Replaced the old ECF component for better user experience and improved functionality. | ### Software Platform Components: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo is simple and clean, with a focus on the company name and affiliation. {6}------------------------------------------------ Image /page/6/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". {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 logo appears to be a company logo. ### Software Deployment: | # | New Deployment (version 7.0) | Reason for Changes | |---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | 5 | Multiple User Workstation Deployment New Deployment: Multi-user multi-modality departmental deployment of the workstation, which allows multiple concurrent user access to the workstation at the same time without degrading the performance. | To extend the capabilities of the workstation to multiple (currently up to 3) concurrent users. | ### Intended for Disease / Condition / Patient Population: Vitrea system is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Therefore intended disease, conditions, or patient population information is not applicable. ### Substantial Equivalence Comparison: | Criteria | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------| | Device Type / Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | Same | | Common Name | Radiological Image Processing Software | Radiological Image Processing Software | Same | | Regulation / Classification Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Product Code | LLZ | LLZ | Same | | Classification | Class II | Class II | Same | | Review Panel | Radiology | Radiology | Same | #### ● Regulatory Comparison {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 word "VITAL" is the main focus of the image, with the company affiliation provided as additional context. | Criteria | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for Use | Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi- dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. | Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi- dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. | Same | #### Intended Use Comparison ● #### Device Description Comparison ● | Device Description | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------| | General Description: | | | | | The Vitrea system is a medical diagnostic device that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. | Same | Same | Same | | Device Description | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | The Vitrea system provides multi- dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. | Same | Same | Same | | The Vitrea system user interface follows typical clinical workflow patterns to process, review, and analyze digital images. | Same | Same | Same | | Key Features: | | | | | Retrieve image data over the network via DICOM. | Same | Same | Same | | Display images that are automatically adapted to exam type via dedicated protocols. | Same | Same | Same | | Select images for closer examination from a gallery of up to six 2D or 3D views. | Same | Same | Same | | Interactively manipulate an image in real-time to visualize anatomy and pathology. | Same | Same | Same | | Annotate, tag, measure, and record selected views. | Same | Same | Same | | Output selected views to standard film or paper printers, or post a report to an intranet Web server or export views to another DICOM device | Same | Same | Same | | Retrieve reports that are archived on a Web server. | Same | Same | Same | | Software Functionality | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | General Features: | | | | | Selection and loading a patient study Component: "Study Directory" (old name) / "AppShell / Vitrea Client and Study List" (new name) | Same | Same | Same | | Selection of protocol and preset for patient study Component: Gallery Window | Same | Same | Same | | Visualization and analysis of patient study Component: Viewer Window | Same | Same | Same | | Allows access to the visual, analysis, and batch pages Component: Viewer Window | Same | Same | Same | | Segment, trim, sculpt, perform measurements, and change display settings Component: Viewer Window | Same | Same | Same | | Record images, batches of images, and movies for physician reporting Component: Viewer Window | Same | Same | Same | | Creation of a report for the patient study) data publishing and archiving Component: Report Window | Same | Same | Same | | Software Functionality | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | Review of report for any patient study Component: Report Window | Same | Same | Same | | Help on Vitrea software Component: Help Window | Same | Same | Same | | DICOM Compliance and Data Management | Same | Same | Same | | Data Security and HIPAA Compliance | Same | Same | Same | | Picture Achieving and Communication System (PACS) Information Sharing | Same | Same | Same | | Multi-vendor scanner compatibility | Same | Same | Same | | Integrated 2D and 3D visualization measurements | Same | Same | Same | | Interactive navigation in 3D | Same | Same | Same | | Large data set capability, including the ability to render multi-detector computed tomography (MDCT) data | Same | Same | Same | | Multi-modality Support | Same | Same | Same | | Vitrea Basic Clinical Toolset: | | | | | Retrieve image data over the network | Same | Same | Same | | Display images that are automatically adapted to exam type via dedicated protocols | Same | Same | Same | | Software Functionality | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | Select images for closer examination from a gallery of up to six 2D or 3D views | Same | Same | Same | | Interactively manipulate an image in real-time to visualize anatomy and pathology | Same | Same | Same | | Annotate, tag, measure, and record selected views | Same | Same | Same | | Output selected views to standard film or paper printers, or post a report to an Intranet | Same | Same | Same | | Study List (old name- Study Directory Window): | | | | | Automatic reading and display of demographic and scanner information including Patient, ID, Date, Time, Series, Modality, Exam Type, Thickness/Spacing, and the number of images in the series | Same | Same | Same | | Each patient entry can include multiple series of image data | Same | Same | Same | | Fully sortable listing of all studies present on the system to optimize data searching and selection for users, along with user-specific filters | Same | Same | Same | | Preview of an image of the selected series to ensure its applicability | Same | Same | Same | | Customization of the layout of study list to each user's personal preference | Same | Same | Same | | Software Functionality | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | Series thumbnail display indicating available series | Same | Same | Same | | Display of selected images, series, or entire study and loading of multiple series or studies for simultaneous analysis and review | Same | Same | Same | | Direct launch into 2D or 3D workflow for a study or series | Same | Same | Same | | Display image findings and reports in the Evidence Manager | Same | Same | Same | | Retrieve reports that are archived on a Web server | Same | Same | Same | | Gallery Window: | | | | | Unique clinical protocols based on anatomy, workflow, and image type | Same | Same | Same | | Automatic pre-selection of clinical protocol of images to exam type, as indicated in the DICOM header fields | Same | Same | Same | | Easy selection of up to six independent 2D and 3D views of selected image data for review, optimized and rendered based on the clinical protocol | Same | Same | Same | | Ability to return to the Gallery window at any time to select other views, or to select alternative protocols | Same | Same | Same | | Software Functionality | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | Customized presets that can be created in the Viewer window for display and selection in the Gallery window (one custom preset for each view available for any of the protocols) | Same | Same | Same | | Viewer Window: | | | | | A choice of four 2D review and four 3D display formats, as well as a 2D "All Exams" comparative viewer that allows the user to display up to nine series on the screen at once | Same | Same | Same | | Pick tabs in both 2D comparative and 2D montage formats, allowing the user to change the orientation of the image views and the order of the series displayed in comparative viewing | Same | Same | Same | | Simultaneous view of 3D volume-rendered projections and correlated multi-planar reformatted projections (MPRs) | Same | Same | Same | | Orthogonal, Oblique, Double Oblique, and Curved MPRs | Same | Same | Same | | Cross-reference lines (Crosshairs) to identify and correlate point of interest in all 2D and 3D views | Same | Same | Same | | Ability to navigate, scroll, pan, cine, zoom, rotate, flip, invert interactively that lets the user select, edit, measure, annotate, and record the optimum 2D and 3D views for diagnosis and reporting | Same | Same | Same | | Software Functionality | Legally Marketed Device Vitrea, Medical Image Processing Software, version 4.0 (K071331) (Predicate Device) | Modified Subject Device Vitrea, Medical Image Processing Software, version 7.0 | Comparison | | Navigation through or around the 3D view selected (Fly-around, Fly-through, Point-of-interest) | Same | Same | Same | | Adjustment of window/level on screen interactively | Same | Same | Same | | Adjustment of a broad range of imaging controls and displays such as rendering (Normal, Min/Max Intensity Projections), brightness, contrast, shading, transparency, and color | Same | Same | Same | | Image segmentation using any of several segmentation methods (trimming, freehand/box sculpting, semi- automated vessel inclusion/bone removal based on threshold and connectivity) | Same | Same | Same | | Variable size slab reformat and rendering | Same | Same | Same | | Annotation of the images with embedded 3D arrows and text | Same | Same | Same | | Distance measurements using ruler and area and volume measurements using ellipse or freehand ROI | Same | Same | Same | | Keyboard shortcuts for many functions | Same | Same | Same | | Creation of custom visualization presets to appear in the Gallery Tab…