# K152279: ViZion DR + Wireless

- Pathway: 510(k) (Special)
- Applicant: Viztek, LLC
- Decided: Sep 10, 2015 after 29 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: 9 generations back to K981556 (1998). 20 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123644: Vizion + DR, Viztek, LLC (2013) Summary page 4.

## Most influential descendants
- K161730: Wireless Digital Flat Panel Detector (2016), 24 descendants of its own
- K182551: Wireless Digital Flat Panel Detector (2018), 18 descendants of its own
- K183713: Wireless Digital Flat Detector (2019), 9 descendants of its own
- K201043: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) (2020), 7 descendants of its own
- K210314: Mars1717X Wireless Digital Flat Panel Detector (2021), 4 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/K152279
Methodology: https://510kreport.com/methodology