# K011292: Ziehm Vision

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm International, Inc.
- Decided: Jun 20, 2001 after 51 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K061534: Ziehm Vision FD Digital Mobile Imaging System (2006), 34 descendants of its own
- K073346: Ziehm Vision 2 (2008), 28 descendants of its own
- K061203: Ziehm Vision R Digital Mobile Imaging System (2006), 18 descendants of its own
- K083545: Ziehm Vision RFD (2009), 17 descendants of its own
- K132904: Ziehm Vision RFD (2013), 16 descendants of its own

Source page: https://510kreport.com/device/K011292
Methodology: https://510kreport.com/methodology