# K241038: Cardiac CT Function Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging
- Decided: Jun 7, 2024 after 52 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 K913770 (1991). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141302: Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa), Vital Images, Inc. (2014) Summary page 4.

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

## Indications for use
The Cardiac CT Function Software Application is indicated to be used with multi-phase, multi-slice cardiovascular CT angiography images to assist qualified medical professionals in assessing and evaluating cardiac function. CT Function includes manual and semi-automatic heart segmentation of 2 chambers (LV and RV) and calculation of cardiac function metrics including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and LV myocardial mass.

Source page: https://510kreport.com/device/K241038
Methodology: https://510kreport.com/methodology