# K232661: Myocardial Strain Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging
- Decided: Dec 7, 2023 after 98 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 K935595 (1995). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120135: 2D Cardiac Performance Analysis MR 1.0, Tomtec Imaging Systems GmbH (2012) Summary page 5.

## Most influential descendants
- K242781: cvi42 Software Application (2024), 0 descendants of its own

## Indications for use
The Myocardial Strain Software Application is intended for qualitative and quantitative evaluation of cardiovascular magnetic resonance (CMR) images. It provides measurements of 2D LV myocardial function (displacement, velocity, strain, strain rate, time to peak, and torsion); these measurements are used by qualified medical professionals, experienced in examining and evaluating CMR images, for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process.

Source page: https://510kreport.com/device/K232661
Methodology: https://510kreport.com/methodology