# K083181: QV-9000 Universal System

- Pathway: 510(k) (Special)
- Applicant: Quantum Medical Imaging, LLC
- Decided: Nov 26, 2008 after 29 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: 2 generations back to K870856 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023008: Universal System, Model QV-800, Quantum Medical Imaging, LLC (2002) Summary page 1.

## Indications for use
The QV-9000 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/K083181
Methodology: https://510kreport.com/methodology