# K042257: Discovery ST Pet/CT Imaging System with an Alternate Detector Option

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Sep 8, 2004 after 19 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: 1 generation back to K010641 (2001). 1 ancestor in all.
14 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010641: GE CT-Pet System, Ge Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K050559: GE Discovery VCT System (2005), 13 descendants of its own
- 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

## Recalls of this device
- Jan 26, 2006 · Not classified · Z-0588-06: The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.

## Indications for use
The GE Discovery ST System with the alternate detector option 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 ST with alternate detector option 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 ST with alternate detector option 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/K042257
Methodology: https://510kreport.com/methodology