# K040172: Modification to GE Discovery LS System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Apr 7, 2004 after 72 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010641 (2001). 2 ancestors in all.
463 later devices descend from it; 4 cite it directly.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023988: GE Discovery LS System, GE Medical Systems (2003) Summary page 1.

## Most influential descendants
- 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
- K091373: Syngo Trued (2009), 200 descendants of its own

## Recalls of this device
- Feb 10, 2016 · Class II · Z-1049-2016: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
- Feb 10, 2016 · Class II · Z-1050-2016: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
- Feb 10, 2016 · Class II · Z-1052-2016: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
- Jul 17, 2015 · Class II · Z-2801-2015: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
- Jul 17, 2015 · Class II · Z-2802-2015: 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 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, 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 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/K040172
Methodology: https://510kreport.com/methodology