# K973396: Quest Pet Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ugm Medical Systems, Inc.
- Decided: Jan 21, 1998 after 149 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 K930428 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930428: Penn-Pet Scanner, Ugm Medical Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- K042839: C-Pet Plus Imaging System (2004), 0 descendants of its own

## Indications for use
The Quest Positron Emission Tomography (PET) system is a whole body scanner designed to provide true volumetric imaging. Quest is intended for use as a diagnostic imaging device. When used with appropriate radiopharmaceuticals, it produces images representative of the internal distribution of radioactivity in the head or the body. PET is based on the fact that certain radionuclides decay by positron emission. The positron annihilation results in the emission of two 511 keV gamma-rays which are emitted in opposite directions. Coincidence detection of both gamma rays localizes the decay along a line. By using 6 large position-sensitive detectors around the patient, counts along many parallel lines and at many angles are acquired simultaneously. By using reconstruction algorithms, the internal distribution of radioactivity can be determined.

Source page: https://510kreport.com/device/K973396
Methodology: https://510kreport.com/methodology