# K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Apr 3, 2002 after 12 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: 3 generations back to K945512 (1995). 3 ancestors in all.
272 later devices descend from it; 5 cite it directly.
1 of 276 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982004: CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows, General Electric Co. (1998) Summary page 1.

## Most influential descendants
- K022919: Smart Breath Respiratory Compensation Option (2002), 217 descendants of its own
- K032915: Advantage 4D Option (2003), 216 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own

## Indications for use
SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

Source page: https://510kreport.com/device/K020929
Methodology: https://510kreport.com/methodology