# K963273: Vcar Option to Vision FX-80 Gamma Camera and Power Station

- Pathway: 510(k) (Traditional)
- Applicant: Smv America
- Decided: Mar 11, 1997 after 203 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: 1 generation back to K930428 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930428: Penn-Pet Scanner, Ugm Medical Systems, Inc. (1993) Summary page 1.
- K952684: Vertex Epic MCD, Adac Laboratories (1995) Summary page 1.

## Most influential descendants
- K972686: Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer (1997), 0 descendants of its own

## Indications for use
The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.

Source page: https://510kreport.com/device/K963273
Methodology: https://510kreport.com/methodology