# K102123: Vizion DR

- Pathway: 510(k) (Traditional)
- Applicant: Viztek, Inc.
- Decided: Jan 24, 2011 after 179 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). 14 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082604: Viztek DR, Models: DR1000, DR3000, DR4000, Viztek, Inc. (2008) Summary page 1.
- K063337: Opal-Rad, Viztek, Inc. (2006) Summary page 1.

## Most influential descendants
- K112661: Vizion DR (2011), 34 descendants of its own
- K123644: Vizion + DR (2013), 33 descendants of its own
- 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

## Indications for use
ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediatric, 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/K102123
Methodology: https://510kreport.com/methodology