# K160810: ViZion DR + Wireless

- Pathway: 510(k) (Traditional)
- Applicant: Viztek, LLC
- Decided: May 20, 2016 after 57 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 10 generations back to K981556 (1998). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152279: ViZion DR + Wireless, Viztek, LLC (2015) Summary page 4.

## Most influential descendants
- K191645: SKR 4000 (2019), 0 descendants of its own

## Indications for use
Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion DR + Wireless allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities..

Source page: https://510kreport.com/device/K160810
Methodology: https://510kreport.com/methodology