# K982004: CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Aug 18, 1998 after 71 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 K945512 (1995). 2 ancestors in all.
274 later devices descend from it; 2 cite it directly.
1 of 277 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970980: Cardiac Scoring for CT Scanners, Elscint, Inc. (1997) Summary page 1.

## Most influential descendants
- K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 (2002), 272 descendants of its own
- 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

## Indications for use
The CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).

Source page: https://510kreport.com/device/K982004
Methodology: https://510kreport.com/methodology