# K061534: Ziehm Vision FD Digital Mobile Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: Jul 7, 2006 after 35 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
Longest line of descent: 1 generation back to K011292 (2001). 1 ancestor in all.
34 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011292: Ziehm Vision, Ziehm International, Inc. (2001) Summary page 1.

## Most influential descendants
- K073346: Ziehm Vision 2 (2008), 28 descendants of its own
- K083545: Ziehm Vision RFD (2009), 17 descendants of its own
- K132904: Ziehm Vision RFD (2013), 16 descendants of its own
- K142740: Ziehm Vision RFD 3D (2015), 10 descendants of its own
- K092438: Ziehm Solo (2009), 9 descendants of its own

## Indications for use
The Zichm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patieats during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.

Source page: https://510kreport.com/device/K061534
Methodology: https://510kreport.com/methodology