# K112531: Vitrea CT Myocardial Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Nov 18, 2011 after 79 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: 8 generations back to K971684 (1997). 31 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073138: Cardiq Express Version 2.0, GE Medical Systems (2008) Summary page 1.
- K110366: Syngo.CT Cardiac Function, Siemens AG (2011) Summary page 1.

## Most influential descendants
- K151212: Ziostation2 (2015), 2 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K132523: Myoperfusion (2013), 1 descendant of its own
- K201250: SQuEEZ Software (2020), 0 descendants of its own
- K200315: Ziostation2 (2020), 0 descendants of its own

## Indications for use
Vitrea® CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.

Source page: https://510kreport.com/device/K112531
Methodology: https://510kreport.com/methodology