# K141302: Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Aug 1, 2014 after 74 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: 7 generations back to K913770 (1991). 27 ancestors in all.
2 later devices descend 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)
- K043333: VITREA2, Version 3.7 Medical Image Processing System, Vital Images, Inc. (2004) Summary page 4.
- K073153: Cardiq Function Xpress, GE Medical Systems SCS (2008) Summary page 4.

## Most influential descendants
- K241038: Cardiac CT Function Software Application (2024), 1 descendant of its own
- K242781: cvi42 Software Application (2024), 0 descendants of its own

## Indications for use
The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.

Source page: https://510kreport.com/device/K141302
Methodology: https://510kreport.com/methodology