# K211247: Pet Vcar

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Jul 27, 2021 after 92 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: 7 generations back to K913770 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063324: Pet Vcar, GE Healthcare (2007) Summary page 4.

## Most influential descendants
- K251883: MIM – LesionID Pro (2025), 0 descendants of its own

## Indications for use
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy usingz multi exam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow, which is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.

Source page: https://510kreport.com/device/K211247
Methodology: https://510kreport.com/methodology