# K033774: CT-Mass

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Mar 2, 2004 after 90 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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) Summary page 1.
- K020796: Card IQ Analysis II, GE Medical Systems (2002) Summary page 1.

## Indications for use
CT-MASS has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets. The itended purposes are: 1. Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart; 2. Supporting the subsequent clinical decision making processes; 3. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

Source page: https://510kreport.com/device/K033774
Methodology: https://510kreport.com/methodology