# K132523: Myoperfusion

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Dec 12, 2013 after 122 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112531: Vitrea CT Myocardial Analysis, Vital Images, Inc. (2011) Summary page 2.
- K073138: Cardiq Express Version 2.0, GE Medical Systems (2008) Summary page 2.
- K110366: Syngo.CT Cardiac Function, Siemens AG (2011) Summary page 2.

## Most influential descendants
- K150104: Vitrea CT Myocardial Perfusion (2015), 0 descendants of its own

## Recalls of this device
- Jun 13, 2014 · Class II · Z-2085-2014: Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may 

## Indications for use
This software is intended to be used for the visualization of non-reversible perfusion defects (hypo/hyper dense areas) in patients with angina or with a previous myocardial infarct. Included software tools may aid a trained user in monitoring the disease state and treatment over time. This software provides maps and the values used to generate the maps. 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/K132523
Methodology: https://510kreport.com/methodology