# K122136: Vitreaview

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Sep 7, 2012 after 51 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904519 (1991). 12 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111892: Vitreaview Software 6.1, Vital Images, Inc. (2011) Summary page 1.

## Most influential descendants
- K150738: VitreaView (2015), 8 descendants of its own
- K163232: Vitrea View (2017), 7 descendants of its own
- K190764: SurgicalAR (2019), 6 descendants of its own
- K121916: Intuition (2013), 5 descendants of its own
- K213215: VSI HoloMedicine (2022), 2 descendants of its own

## Indications for use
VitreaView is a medical image viewing and information distribution application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis. When accessed from a mobile tablet, VitreaView is for informational purposes only and not intended for diagnostic use. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K122136
Methodology: https://510kreport.com/methodology