# K151091: Vitrea Software Toshiba Package, VSTP-001A

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jul 13, 2015 after 81 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). 50 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150258: Vitrea, Version 7.0 Medical Image Processing Software, Vital Images, Inc. (2015) Summary page 5.
- K120487: Vantage Titan 3T, Toshibamedical Systems Corporation (2012) Summary page 5.
- K142465: Aquilion ONE Vision, v7.0, Toshibamedical Systems Corporation (2015) Summary page 5.

## Most influential descendants
- 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
- K203312: Vitrea Software Package, VSTP-001A (2021), 7 descendants of its own

## Indications for use
Vitrea Software Toshiba Package is an application package developed for use on Vitrea, a medical image processing software, which includes the following post-processing software applications. CT/XA Cerebral Artery Morphological Analysis This software is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio. MR Wall Motion Tracking This application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

Source page: https://510kreport.com/device/K151091
Methodology: https://510kreport.com/methodology