# K012106: Accuimage Smartgate Upgrade

- Pathway: 510(k) (Traditional)
- Applicant: Accuimage Diagnostics Corp.
- Decided: Sep 25, 2001 after 81 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 K980169 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980169: Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems, General Electric Co. (1998) Summary page 3.
- K003230: V Score with Auto Gate Model TBD, Vital Images, Inc. (2000) Summary page 3.

## Indications for use
Heart calcium scoring for gated CT images to minimize effects of heart movements.

Source page: https://510kreport.com/device/K012106
Methodology: https://510kreport.com/methodology