Multi Modality Viewer
Device Facts
| Record ID | K182230 |
|---|---|
| Device Name | Multi Modality Viewer |
| Applicant | Vital Images, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Sep 7, 2018 |
| 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 an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/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 option within the Vitrea system for viewing/manipulating medical images (MRI, CT, CR, DX, RG, RF, US, XA, PET, PET/CT). It enables side-by-side comparison of studies, 2D/3D visualization, and advanced image processing. Clinicians use it to perform measurements, annotations, and segmentations (bone/table). It includes automated rigid registration for current/prior studies. The device is used in clinical settings by healthcare professionals. Output is displayed on the Vitrea interface, assisting clinicians in diagnostic review and clinical decision-making. Benefits include improved workflow efficiency and enhanced visualization of anatomical structures.
Clinical Evidence
No clinical studies were required. Evidence consists of bench testing, software verification, and validation. Validation included workflow testing and external clinical reviews by three evaluators at three clinical sites, confirming functionality, image quality, and safety compared to reference devices. No negative feedback was recorded.
Technological Characteristics
Radiological image processing software; DICOM compliant. Features include 2D/3D rendering, MPR, MIP/MinIP, automated segmentation (bone/table), and automated rigid registration. Connectivity via Vitrea system. Software lifecycle follows IEC 62304. Risk management per ISO 14971.
Indications for Use
Indicated for use by qualified healthcare professionals (radiologists, non-radiology specialists, physicians, technologists) to examine and manipulate medical images from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. No specific patient population, disease, or condition is applicable as it is a general medical image viewer.
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
- Multi Modality Viewer (K163574)
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vital Images, Inc. Fei Li Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA, MN 55343-4414
Re: K182230
Trade/Device Name: Multi Modality Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2018 Received: August 17, 2018
Dear Fei Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
September 7, 2018
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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,
Jeff Balyer
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known) K182230
Device Name Multi Modality Viewer
#### Indications for Use (Describe)
Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/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) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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### 510K Summary, K182230
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 expand<br>the Indications for Use and to establish substantial equivalence<br>between the Multi Modality Viewer Software (subject device) and the<br>FDA cleared predicate device Multi Modality Viewer Software<br>(K163574) and reference devices. |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN, 55343-4414 |
| Establishment<br>Registration: | 2134213 |
| Contact Person: | Fei Li<br>Regulatory Affairs Specialist<br>Phone: 952-487-9739<br>Fax: 952-487-9510<br>E-mail: fli@vitalimages.com<br>Alternate Contact Person:<br>Vince Swenson<br>Sr. Director of Quality and Regulatory<br>Phone: 952-487-9548<br>Fax: 952-487-9510<br>E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | August 16, 2018 |
| Device Trade Name: | Multi Modality Viewer |
| Device Common<br>Name/ Requlatory<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 |
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### Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|-----------------------|--------------------|-------------------|
| Multi Modality Viewer | Vital Images, Inc. | K163574 |
#### Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|----------------------------------|-------------------------------------------------------------------------------------------|-------------------|
| Vitrea Advanced<br>Visualization | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300,<br>Minnetonka, Minnesota 55343 U.S.A. | K172855 |
| Vitrea View | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300,<br>Minnetonka, Minnesota 55343 U.S.A. | K163232 |
| Mirada XD | MIRADA MEDICAL LTD.<br>Mill Street<br>Innovation House<br>Oxford, Oxfordshire, GB Ox2 0JX | K101228 |
#### Device Description:
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/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.
The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
#### Features
General image display:
- Display of images, volumes, and time sequences from MR and CT modalities ●
- Display of images and time sequences from Projection Modality modalities (CR, DX, RF, ● RG, XA)
- Display of images and time sequences from Ultrasound modalities
- Display of PET images in grayscale or with a color map ●
- Display of PET-CT images acquired with the same frame of reference ●
- Display of derived modality images and secondary capture (SC) images ●
- 2D image display, MPR display, cine and 4D cine display for appropriate modalities
- Maximum, minimum, or average intensity projection for MPR with adjustable thickness ● and full volume Maximum Intensity Projection (MIP)
- . Fused display of PET-CT images acquired with the same frame of reference
- Full volume MIP display
- Display of high-resolution (1024 matrix) CT images
- . 3D Volume and Luminance image rendering
3D segmentation:
- Six planes interactive orthogonal clipping box ●
- Manual 3D volume cutting tool ●
- . Automated table segmentation
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- . Automated bone segmentation
- Segmentation correction tools .
Image cross-reference and comparison:
- Single MPR plane, 3-plane orthogonal MPR, and oblique MPR display ●
- Linked scrolling of MPR images and 2D images in the same plane ●
- Linked pan, zoom, and matched presentation of images in the same plane .
- Cross-reference lines and MPR cross-hairs to indicate orthogonal planes ●
- Focus tool to pinpoint the same location in all series ●
- Linking of PET hotspots in MIP and MPR views .
- Automatic linking of series with the same frame of reference .
- Automated rigid registration of current study and/or prior study(ies) with caching of ● automated registration result
- . Manually set reference point for linking separately acquired series
Hanging and viewing adjustments
- Ability to load only one study or including all priors ●
- . User-defined, flexible hanging layouts.
- Automatic initial hanging, manual hanging using drag & drop thumbnails ●
- Scroll, pan, zoom, W/L, W/L presets, fit to view, reset ●
- . lmage flip, rotate clockwise/counter clockwise, invert
- Demographics more, less, on/off, reference lines on/off, linking on/off .
Measurement, annotation, and snapshots:
- Length (ruler), angle, and Cobb angle measurement ●
- Ellipse ROI and freehand ROI with pixel value statistics .
- HU measurement for CT, SUV measurement for PET ●
- . Time-Intensity Analysis ROI
- . Arrow and text annotation
- Manual snapshots. Auto snapshot on measurement or annotation. .
- Ability to restore the presentation state of a snapshot
Derived series and specialized tools:
- MPR batch series generation ●
- lmage subtraction of two compatible series ●
- Direct access to MR Stitching application .
- . Access to all other applications on Vitrea system
### Proposed Intended Use / Indications for Use:
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/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 on the intended for disease, condition, and patient population is not applicable.
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### Key Changes from the last 510(k) clearance K163574:
The following features and tools were added to the Multi Modality Viewer software:
- Full volume MIP
- · Volume image rendering
- 3D Cutting Tool (Manual 3D Segmentation) .
- · Clip Plane Box (Orthogonal Clipping panes)
- · 2-click bone/base separation tool (2-click bone/base segmentation)
- · 1-click bone/base separation tool (1-click bone/base segmentation)
- · 1 Click Visible Seed (1-click segmentation)
- · Automatic table segmentation
- Automatic bone segmentation
- Head/Neck Extremities
- Chest/Abdominal/Pelvis
- US 2D Cine Viewer
- · Automatic Rigid Registration (Auto Linked Navigation of Current and Priors)
# Substantial Equivalence Comparison:
#### Regulatory Comparison:
| | Subject Device | Predicate Device | |
|---------------------|----------------------------------------|----------------------------------------|-----------------------------|
| Characteristic | Multi Modality Viewer | Multi Modality Viewer (K163574) | 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 | Jan 26, 2017 | Predicate device is cleared |
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## FAL Vil
| | Subject Device | Predicate Device | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Criteria | Multi Modality Viewer | Multi Modality Viewer<br>(K163574) | |
| Indications for<br>Use | Multi Modality Viewer is<br>an option within Vitrea<br>that allows the<br>examination and<br>manipulation of a series<br>of medical images<br>obtained from MRI, CT,<br>CR, DX, RG, RF, US, XA,<br>PET, and PET/CT<br>scanners. The option also<br>enables clinicians to<br>compare multiple series<br>for the same patient,<br>side-by-side, and switch<br>to other integrated<br>applications to further<br>examine the data. | Multi Modality Viewer is<br>an option within Vitrea<br>that allows the<br>examination<br>and manipulation of a<br>series of medical images<br>obtained from MRI, CT,<br>CR, DX, RG, RF, XA,<br>PET, and PET/CT<br>scanners. The option<br>also enables clinicians to<br>compare multiple series<br>for the same patient,<br>side-by-side, and switch<br>to other integrated<br>applications to further<br>examine the data. | Similar<br>Added support for the<br>ability to examine and<br>manipulate medical<br>images obtained from<br>US modality which<br>was not part of the<br>predicate device's<br>indications for use. |
| Intended Users | Qualified healthcare<br>professionals including,<br>but not restricted to,<br>radiologists, non-<br>radiology specialists,<br>physicians and<br>technologists. | Qualified healthcare<br>professionals including,<br>but not restricted to,<br>radiologists, non-<br>radiology specialists,<br>physicians and<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. | Multi Modality Viewer<br>software is medical<br>image viewer software.<br>Therefore, particular<br>information of intended<br>for disease, condition,<br>and patient population is<br>not applicable. | Same |
| Modality<br>Support | MRI, CT, CR, DX, RG,<br>RF, US, XA, PET, and<br>PET/CT | CT, MRI, CR, DX, RG,<br>RF, XA, PET, and<br>PET/CT | Similar<br>Added support for the<br>ability to examine and<br>manipulate medical<br>images obtained from<br>US modality which<br>was not part of the<br>predicate device's |
| | Subject Device | Predicate Device | |
| Criteria | Multi Modality Viewer | Multi Modality Viewer<br>(K163574) | 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<br>Multi Modality Viewer | Predicate Device<br>Multi Modality Viewer<br>(K163574) | Comparison |
| Simultaneous Multiple Studies Review | Yes | Yes | Same |
| Cross-reference Lines Support | Yes | Yes | Same |
| Display of Selected Images, Series, or Entire Study | Yes | Yes | Same |
| Comparison of Multiple Series or 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 - Horizontal | Yes | Yes | Same |
| Rotate Image - Clockwise | Yes | Yes | Same |
| Rotate Image - Counter-clockwise | Yes | Yes | Same |
| Invert Image | Yes | Yes…
