# K023988: GE Discovery LS System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Feb 4, 2003 after 64 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.
466 later devices descend from it; 2 cite it directly.
1 of 468 devices in its family (counting itself) has 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 2.

## Most influential descendants
- K040172: Modification to GE Discovery LS System (2004), 463 descendants of its own
- K041543: GE Discovery ST (2004), 396 descendants of its own
- 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

## Recalls of this device
- Dec 8, 2003 · Not classified · Z-0306-04: Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.

## Indications for use
The GE Discovery LS 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 LS 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 and diagnosis of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This can also assist in radiotherapy planning. The Discovery LS 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/K023988
Methodology: https://510kreport.com/methodology