# K241312: TeraRecon Cardiac.Chambers.MR (1.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Nov 5, 2024 after 180 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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 K945512 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213998: cvi42 Auto Imaging Software Application, Circle Cardiovascular Imaging, Inc. (2022) Summary page 5.

## Indications for use
This medical device is intended to segment Cardiac chambers as anatomical structures on contrast or non-contrast MR scans of adult patients that undergo Cardiac MR procedures. The algorithm is not specific to any gender or ethnic group or clinical conditions.

Source page: https://510kreport.com/device/K241312
Methodology: https://510kreport.com/methodology