# K001682: Vscore with Ekg Signal Gating

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Jun 30, 2000 after 29 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.
48 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have 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
- K072737: CSCS-001A Calcium Scoring Package (2007), 45 descendants of its own
- K083446: Cardiac Function Analysis, Calcium Scoring (2009), 29 descendants of its own
- K111373: CT42 Cardiac Computed Tomography (CT) Software (2011), 25 descendants of its own
- K203256: Imbio RV/LV Software (2021), 17 descendants of its own
- K172983: HealthCCS (2018), 14 descendants of its own

Source page: https://510kreport.com/device/K001682
Methodology: https://510kreport.com/methodology