# K972686: Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer

- Pathway: 510(k) (Traditional)
- Applicant: Smv America
- Decided: Oct 14, 1997 after 89 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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 K930428 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963273: Vcar Option to Vision FX-80 Gamma Camera and Power Station, Smv America (1997) Summary page 1.
- K930428: Penn-Pet Scanner, Ugm Medical Systems, Inc. (1993) Summary page 1.
- K952684: Vertex Epic MCD, Adac Laboratories (1995) Summary page 1.

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

Source page: https://510kreport.com/device/K972686
Methodology: https://510kreport.com/methodology