# K061203: Ziehm Vision R Digital Mobile Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: Jun 19, 2006 after 49 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011292 (2001). 3 ancestors in all.
18 later devices descend from it; 1 cites it directly.
2 of 22 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.
- K021049: Oec 9800 Plus Digital Mobile Imaging System, Ge Oec Medical Systems (2002) Summary page 1.
- K024012: Oec 9800 E/CV+ Digital Mobile Imaging System, Ge Oec Medical Systems (2003) Summary page 1.

## Most influential descendants
- 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
- K202360: Ziehm Vision RFD 3D (2020), 4 descendants of its own
- K231701: Ziehm Vision RFD 3D (2023), 3 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-0577-2025: Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with resp
- Apr 15, 2016 · Class II · Z-2642-2016: Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
- Nov 21, 2013 · Class II · Z-0567-2014: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
- Apr 29, 2011 · Not classified · Z-1430-2012: On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional con

## Indications for use
The Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the physician's discretion the device may be used for other imaging applications. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Source page: https://510kreport.com/device/K061203
Methodology: https://510kreport.com/methodology