# K163232: Vitrea View

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Jul 21, 2017 after 246 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: 11 generations back to K913770 (1991). 52 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150738: VitreaView, Vital Images, Inc. (2015) Summary page 4.

## Most influential descendants
- K190764: SurgicalAR (2019), 6 descendants of its own
- K213215: VSI HoloMedicine (2022), 2 descendants of its own
- K230249: Ikshana (2023), 1 descendant of its own
- K253486: SKIA-Head (Model: SKIA-ST00) (2026), 0 descendants of its own
- K251577: Laia XR (2026), 0 descendants of its own

## Indications for use
Vitrea View software 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 (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists. When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

Source page: https://510kreport.com/device/K163232
Methodology: https://510kreport.com/methodology