# K050559: GE Discovery VCT System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Mar 17, 2005 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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: 4 generations back to K010641 (2001). 6 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041543: GE Discovery ST, GE Healthcare (2004) Summary page 1.
- K042257: Discovery ST Pet/CT Imaging System with an Alternate Detector Option, General Electric Co. (2004) Summary page 1.

## Most influential descendants
- K081496: Optima Pet/CT 560 (2008), 10 descendants of its own
- K133657: Discovery Pet/CT 710 (2014), 7 descendants of its own
- K161574: Discovery MI (2016), 5 descendants of its own
- K211846: Discovery MI Gen2 (2021), 3 descendants of its own
- K221932: Omni Legend (2022), 2 descendants of its own

## Recalls of this device
- Dec 21, 2006 · Not classified · Z-0806-2007: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

## Indications for use
The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery VCT is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

Source page: https://510kreport.com/device/K050559
Methodology: https://510kreport.com/methodology