# K032823: Medicheart, Model Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Medicsight
- Decided: Nov 10, 2003 after 61 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: 4 generations back to K945512 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5, GE Medical Systems (2002)
- K013146: Viatronic V3D Calcium Scoring, Viatronix, Inc. (2001) Summary page 1.
- K020140: Voxar's Calcium Scoring Product, Voxar Limited (2002)

## Indications for use
MedicHeart 1 is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.

Source page: https://510kreport.com/device/K032823
Methodology: https://510kreport.com/methodology