# K012775: GE Positrace/Discovery VI Pet/CT Dual Mode Oncology Scanner

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Sep 18, 2001 after 29 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001681 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001681: Positrace Dual Mode Pet/CT Oncology System, Smv America (2000) Summary page 1.

## Indications for use
Combination of whole-body positron emission tomography (PET) scanning with a diagnostic quality computed tomography scanner. Intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images which depict the anatomical distribution of radicisotopes within the human body. The integrated CT system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body. It will also provide registration of anatomical and physiological images to localize the radioisotope activity in the patient anatomy. The CT or PET scanner may be used independently.

Source page: https://510kreport.com/device/K012775
Methodology: https://510kreport.com/methodology