# K150258: Vitrea, Version 7.0 Medical Image Processing Software

- Pathway: 510(k) (Special)
- Applicant: Vital Images, Inc.
- Decided: Mar 5, 2015 after 30 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: 10 generations back to K913770 (1991). 35 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 4.

## Most influential descendants
- K151091: Vitrea Software Toshiba Package, VSTP-001A (2015), 13 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own
- K192923: Vitrea Software Package (2020), 8 descendants of its own

## 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.

Source page: https://510kreport.com/device/K150258
Methodology: https://510kreport.com/methodology