# K123644: Vizion + DR

- Pathway: 510(k) (Special)
- Applicant: Viztek, LLC
- Decided: Jan 11, 2013 after 46 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: 8 generations back to K981556 (1998). 19 ancestors in all.
33 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112661: Vizion DR, Viztek, LLC (2011) Summary page 2.
- K113812: ATAL-8, Atlaim (2012) Summary page 1.

## Most influential descendants
- K152279: ViZion DR + Wireless (2015), 27 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K123644
Methodology: https://510kreport.com/methodology