# K173088: Vitrea Software Toshiba Package VSTP-001A

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 31, 2018 after 124 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: 13 generations back to K913770 (1991). 175 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151091: Vitrea Software Toshiba Package, VSTP-001A, Toshibamedical Systems Corporation (2015) Summary page 5.
- K171222: Vitrea Software Toshiba Package; VSTP-001A, Toshibamedical Systems Corporation (2017) Summary page 5.
- K101228: Mirada XD, Mirada Medical, Ltd. (2010) Summary page 5.
- K081624: Infx-8000F (Infinix Csi and Infinix Dpi), Toshiba America Medical Systems, In.C (2008) Summary page 5.
- K061370: Cardiq Fusion, GE Healthcare (2006) Summary page 5.

## Most influential descendants
- 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
- K213504: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (2022), 6 descendants of its own
- K232835: Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (2024), 3 descendants of its own

## Indications for use
Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, 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 has the following additional indications: The CT/XA Cerebral Artery Morphological Analysis application 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. The MR Wall Motion Tracking 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. The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries. The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images. The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement. The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

Source page: https://510kreport.com/device/K173088
Methodology: https://510kreport.com/methodology