# K023760: CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 22, 2002 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000315 (2000). 2 ancestors in all.
174 later devices descend from it; 3 cite it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013422: Cardiq Function, GE Medical Systems (2001)

## Most influential descendants
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), 143 descendants of its own
- K052632: VITREA2 Version 3.8 Medical Image Processing Software (2005), 117 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own
- K083446: Cardiac Function Analysis, Calcium Scoring (2009), 29 descendants of its own

## Indications for use
The Cardiac Function Analysis (CFA) is a software package that can be used in conjunction with CT cardiac images to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic volumes, stroke volume, LV ejection fraction to include peak filling and ejection rates, Myocardial Mass calculations, regional wall motion display and analysis. When interpreted by a trained physician, the software aids in the assessment and in determination of cardiovascular disease diagnosis and management.

Source page: https://510kreport.com/device/K023760
Methodology: https://510kreport.com/methodology