# K041543: GE Discovery ST

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jun 22, 2004 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: 3 generations back to K010641 (2001). 4 ancestors in all.
396 later devices descend from it; 3 cite it directly.
1 of 401 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022872: GE Road Warrior Pet CT Imaging System, General Electric Co. (2002) Summary page 1.
- K040172: Modification to GE Discovery LS System, GE Medical Systems (2004) Summary page 1.

## Most influential descendants
- K042863: Scenium (2004), 380 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K062163: Mimviewer (2006), 166 descendants of its own

## Recalls of this device
- Jul 17, 2015 · Class II · Z-2803-2015: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

## Indications for use
The GE Discovery ST 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 ST 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 system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system.

Source page: https://510kreport.com/device/K041543
Methodology: https://510kreport.com/methodology