# K080553: Digital Radiography System, Model QXR-16

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: Apr 16, 2008 after 48 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 K973710 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073056: Digital Radiography System, Model: QXR-9, Vieworks Co., Ltd. (2007) Summary page 1.
- (no number) AddOn Multi System: named in the summary without a submission number

## Most influential descendants
- K101779: Clearvision DR 2000 Digital Radiography X-Ray System (2011), 0 descendants of its own
- K082261: Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems (2008), 0 descendants of its own

## Indications for use
QXR-16 Digital Radiography system is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Source page: https://510kreport.com/device/K080553
Methodology: https://510kreport.com/methodology