# K240705: Vitrea Software Package, VSTP-002A V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jul 17, 2024 after 125 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: 19 generations back to K913770 (1991). 190 ancestors in all.
No later device cites it as a predicate yet.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223336: Vitrea Software Package, VSTP-002A, Canon Medical Systems Corporation (2023) Summary page 5.

## Indications for use
Vitrea Software 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 Software Package has the following additional indications: Auto MPR Brain application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position. Subtraction Viewer is a viewer application that is intended for viewing original, subtraction and fusion CT images, but such subtraction processing is not a part of this application. This application supports fusion display of original image and subtraction image generated by other applications.

Source page: https://510kreport.com/device/K240705
Methodology: https://510kreport.com/methodology