# K063324: Pet Vcar

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 23, 2007 after 140 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 14 ancestors in all.
204 later devices descend from it; 3 cite it directly.
1 of 219 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1.
- K042694: Advanced Lung Analysis II, GE Medical Systems (2004) Summary page 1.
- K983256: Advantage Windows (AW) Fusion, GE Medical Systems (1998) Summary page 1.

## Most influential descendants
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own

## Recalls of this device
- May 9, 2013 · Class II · Z-1551-2013: GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or 

## 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. The 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 using 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. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement I image visual validation. PET VCAR's workflow 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/K063324
Methodology: https://510kreport.com/methodology