# K945512: HRSW Option for CT Twin Flash

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Mar 14, 1995 after 125 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
No predicates in its family tree.
525 later devices descend from it; 4 cite it directly.
1 of 526 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970980: Cardiac Scoring for CT Scanners (1997), 276 descendants of its own
- 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
- K982060: Volumax CT Imaging System (1998), 264 descendants of its own
- K012009: MX8000 Idt CT System (2001), 263 descendants of its own

Source page: https://510kreport.com/device/K945512
Methodology: https://510kreport.com/methodology