# K023008: Universal System, Model QV-800

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Medical Imaging, LLC
- Decided: Nov 13, 2002 after 65 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K870856 (1987). 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)
- K870856: Cosmos, Pausch Corp. (1987) Summary page 2.
- (no number) Cares Built Flex-Ray THESEON System: named in the summary without a submission number

## Most influential descendants
- K083181: QV-9000 Universal System (2008), 0 descendants of its own

## Indications for use
The QV-800 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.

Source page: https://510kreport.com/device/K023008
Methodology: https://510kreport.com/methodology