# K970980: Cardiac Scoring for CT Scanners

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: May 29, 1997 after 72 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: 1 generation back to K945512 (1995). 1 ancestor in all.
276 later devices descend from it; 2 cite it directly.
1 of 278 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945512: HRSW Option for CT Twin Flash, Elscint, Inc. (1995) Summary page 1.

## Most influential descendants
- K982004: CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows (1998), 274 descendants of its own
- 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

## Indications for use
Cardiac scoring from whole body computed tomography derived measurements

Source page: https://510kreport.com/device/K970980
Methodology: https://510kreport.com/methodology