Multi Modality Viewer
Device Facts
| Record ID | K161419 |
|---|---|
| Device Name | Multi Modality Viewer |
| Applicant | Vital Images, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Jul 13, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Multi Modality Viewer is a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Device Story
Multi Modality Viewer is a software application operating on the Vitrea platform; it processes DICOM-compliant medical images from MRI and CT scanners. The device provides tools for image navigation, manipulation, and analysis, including 2D/MPR/4D viewing, MIP/MinIP, image subtraction, semi-automated stitching, and measurement tools (distance, angle, Cobb angle, ROIs). It enables side-by-side comparison of multiple series and studies. Used in clinical settings by radiologists, clinicians, or technologists, the software assists in reviewing images to support efficient patient care. Output is displayed on a workstation for clinical decision-making. The device benefits patients by facilitating accurate, efficient diagnostic review and comparison of radiological data.
Clinical Evidence
No clinical studies were required. Safety and effectiveness were supported by bench testing, including software verification (performance and safety testing) and validation (simulated usability testing by experienced professionals).
Technological Characteristics
Software-based radiological image processing application. Operates on the Vitrea platform. Supports DICOM standards (PS 3.1-3.20). Implements standard image manipulation algorithms (MIP/MinIP, registration, subtraction). Complies with ISO 14971 (risk management) and IEC 62304 (software lifecycle).
Indications for Use
Indicated for clinicians, radiologists, or technologists to examine and manipulate medical images from MRI and CT scanners for patient care. No specific patient population, disease, or condition limitations apply.
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
- MR Core Software (K151115)
Reference Devices
- Softread Software (Vitrea® 2, Version 3.5 Medical Image Processing Software) (K040305)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Vital Images, Inc. % Ms. Katie Ryan Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414
Re: K161419
Trade/Device Name: Multi Modalitv Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2016 Received: May 23, 2016
Dear Ms. Ryan:
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
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Page 2-Ms. Katie Ryan
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
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
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## Indications for Use
510(k) Number (if known) K161419
Device Name Multi Modality Viewer
Indications for Use (Describe)
Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> × </span> </div> |
|----------------------------------------------|-------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> </span> </div> |
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# 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<br>Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to obtain<br>510(k) clearance for the Multi Modality Viewer software which is<br>substantially equivalent to the FDA cleared MR Core Software<br>(K151115). |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN, 55343-4414 |
| Establishment<br>Registration: | 2134213 |
| Contact Person: | Katie Ryan, M.S.<br>Regulatory Affairs Specialist<br>Phone : 952-487-9793<br>Fax: 952-487-9510<br>E-mail: kryan@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | May 20, 2016 |
| Device Trade Name: | Multi Modality Viewer |
| Device Common<br>Name/ Regulatory<br>Description: | Radiological Image Processing Software, Picture Archiving and<br>Communications System |
| Device Classification<br>Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory<br>Classification: | Class II |
| Device Panel: | Radiology |
## Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|------------------|--------------------|-------------------|
| MR Core Software | Vital Images, Inc. | K151115 |
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## Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|---------------------------------------------------------------------------------------|--------------------|-------------------|
| Softread Software<br>(Vitrea® 2, Version 3.5<br>Medical Image Processing<br>Software) | Vital Images, Inc. | K040305 |
## Device Description:
Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data.
lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care.
#### Key features:
General Viewing:
- · Linked 2D, MPR and 4D viewers for single and multi-study comparison
- · Creation of retrievable evidence and snapshots
- · User defined flexible display protocols
Access to Advanced Applications and Workflows:
- In application access to MR Stitching application
- · Evidence creation and sharing across workflows
General Image Display, Manipulation, and Analysis Tools:
- · Maximum and Minimum Intensity Projection (MIP/MinIP)
- · Identification and Display of Regions of Interest (ROIs)
- · CINE image display
- · Multi-frame display
- · Color image display
- . Simultaneous multiple studies review
- · Cross-reference lines support
- Display of selected images, series, or entire study .
- · Comparison of multiple series or studies
- · Scroll
- Pan
- Zoom
- · Focus
- · Flip (Vertically, horizontally)
- Invert
- · Rotate (Clockwise, counter-clockwise)
- · Arrow
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- · Adjust Registration
- · Auto window level/width setting
- · Text/Arrow annotation (Label)
- · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI
Specialized Tools:
- · Image subtraction of two series/datasets
- · Access to semi-automated image stitching
- Study and series linking .
- · Register two different series or groups that do not share a frame of reference to link them spatially
## Intended Use / Indications for Use:
Multi Modality Viewer is a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
## Intended for Disease / Condition / Patient Population:
Multi Modality Viewer is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable.
# Substantial Equivalence Comparison:
## Regulatory Comparison:
| | Subject Device | Predicate Device | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Multi Modality<br>Viewer | MR Core<br>Software<br>(K151115) | Comparison |
| Classification Name | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>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 | June 3, 2015 | Predicate device<br>is cleared |
| | Subject Device | Predicate Device | Comparison |
| Criteria | Multi Modality Viewer | MR Core Software<br>(K151115) | Comparison |
| Indications for<br>Use | Multi Modality Viewer is<br>a software application<br>within Vitrea® that<br>allows the examination<br>and manipulation of a<br>series of medical<br>images obtained from<br>MRI and CT scanners.<br>The option also<br>enables clinicians to<br>compare multiple series<br>for the same patient,<br>side-by-side, and<br>switch to other<br>integrated applications<br>to further examine the<br>data. | MR Core is an option<br>within Vitrea® that allows<br>the examination and<br>manipulation of a series<br>of medical images<br>obtained from MRI<br>scanners.<br>The option also enables<br>clinicians to compare<br>multiple series for the<br>same patient, side-by-<br>side, and switch to other<br>integrated applications to<br>further exam the data. | Similar<br>Added support for the<br>ability to examine and<br>manipulate medical<br>images obtained from<br>CT scanners was not<br>part of the predicate<br>device's indications for<br>use. |
| Intended Users | Radiologists, Clinicians<br>or Technologists | Radiologists, Clinicians or<br>Technologists | Same |
| Patient<br>Population | Multi Modality Viewer is<br>medical image viewer<br>software. Therefore,<br>particular information of<br>intended for disease,<br>condition, and patient<br>population is not<br>applicable. | MR Core Software is<br>medical image viewer<br>software. Therefore,<br>particular information of<br>intended for disease,<br>condition, and patient<br>population is not<br>applicable. | Same |
| Modality<br>Support | CT and MRI | MRI | Similar<br>Added support for the<br>ability to examine and<br>manipulate medical<br>images obtained from<br>CT scanners was not<br>part of the predicate<br>device's indications for<br>use. |
| | Subject Device | Predicate Device | |
| Criteria | Multi Modality Viewer | MR Core Software<br>(K151115) | Comparison |
| Data Loading | | | |
| Image<br>Communication<br>Standard: DICOM | Yes | Yes | Same |
| Data Viewing Support | | | |
| 2D Image Review | Yes | Yes | Same |
| 2D Comparative<br>Review | Yes | Yes | Same |
| Features and Capabilities | | | |
| Multi-Planner<br>Reformatting | Yes | Yes | Same |
| Maximum and<br>Minimum Intensity<br>Projection<br>(MIP/MinIP) | Yes | Yes | Same |
| Image Editing,<br>Setting, Saving | Yes | Yes | Same |
| Annotation &<br>Tagging Tools<br>(Label) | Yes | Yes | Same |
| Display Options<br>(e.g. thickness) | Yes | Yes | Same |
| Quantitative<br>Measurements | Yes | Yes | Same |
| Snapshot | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Same |
| Color Image Display | Yes | Yes | Same |
| Criteria | Subject Device | Predicate Device | |
| | Multi Modality Viewer | MR Core Software<br>(K151115) | Comparison |
| Simultaneous<br>Multiple Studies<br>Review | Yes | Yes | Same |
| Cross-reference<br>Lines Support | Yes | Yes | Same |
| Display of Selected<br>Images, Series, or<br>Entire Study | Yes | Yes | Same |
| Comparison of<br>Multiple Series or<br>Studies | Yes | Yes | Same |
| Scroll Image | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
| Pan Image | Yes | Yes | Same |
| Focus Image | Yes | Yes | Same |
| Rotate Image | Yes | Yes | Same |
| Flip Image - Vertical | Yes | Yes | Same |
| Flip Image -<br>Horizontal | Yes | Yes | Same |
| Rotate Image -<br>Clockwise | Yes | Yes | Same |
| Rotate Image -<br>Counter-clockwise | Yes | Yes | Same |
| Invert Image | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Auto Window<br>Level/Width Setting | Yes | Yes | Same |
| Measurement of<br>Distance | Yes | Yes | Same |
| Measurement of<br>Angle | Yes | Yes | Same |
| Criteria | Subject Device<br>Multi Modality Viewer | Predicate Device<br>MR Core Software<br>(K151115) | Comparison |
| Measurement of<br>Cobb Angle | Yes | Yes | Same |
| Identification and<br>Display of Ellipse<br>Regions of Interest<br>(ROIs) | Yes | Yes | Same |
| Identification and<br>Display of Freehand<br>Regions of Interest<br>(ROIs) | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Same |
| Image subtraction of<br>two series/datasets | Yes | Yes | Same |
| Study and Series<br>Linking | Yes | Yes | Same |
| Semi-automated<br>image stitching | Yes | Yes | Same |
| Time Intensity<br>Analysis | Yes | Yes | Same |
| Batch Save of<br>MPR reformats | Yes | Yes | Same |
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## Indications for Use Comparison with Predicate Device:
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## Similarities in Technology with Predicate Device:
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| | Subject Device | Predicate Device | |
|------------------------------------------|-----------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…
