# K133139: Vizion Ultra

- Pathway: 510(k) (Special)
- Applicant: Viztek, LLC
- Decided: Apr 3, 2014 after 168 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.
No later device cites it as a predicate yet.
0 of 21 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 1.
- K123644: Vizion + DR, Viztek, LLC (2013) Summary page 1.

## Indications for use
ViZion Ultra 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 Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities,

Source page: https://510kreport.com/device/K133139
Methodology: https://510kreport.com/methodology