# K150104: Vitrea CT Myocardial Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Apr 17, 2015 after 87 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K971684 (1997). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132523: Myoperfusion, Toshibamedical Systems Corporation (2013) Summary page 5.
- K112531: Vitrea CT Myocardial Analysis, Vital Images, Inc. (2011) Summary page 5.

## Indications for use
Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue. The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Source page: https://510kreport.com/device/K150104
Methodology: https://510kreport.com/methodology