# K082261: Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dxrad Solutions, Ltd.
- Decided: Nov 6, 2008 after 90 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: 6 generations back to K981556 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012546: Optima Urs Universal Radiographic System, Sedecal USA, Inc. (2001) Summary page 1.
- K073056: Digital Radiography System, Model: QXR-9, Vieworks Co., Ltd. (2007) Summary page 1.
- K080553: Digital Radiography System, Model QXR-16, Vieworks Co., Ltd. (2008) Summary page 1.
- K071193: Vidar Vision 3000 and 4000 X-Ray Systems, Vidar Systems Corp. (2007) Summary page 1.

## Indications for use
These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, ahdomen, extremities, and other body parts. Applications can be performed with the pationt sitting, standing, or lying in the pronc or supine position,

Source page: https://510kreport.com/device/K082261
Methodology: https://510kreport.com/methodology