# K083545: Ziehm Vision RFD

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: May 15, 2009 after 168 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003266 (2000). 11 ancestors in all.
17 later devices descend from it; 1 cites it directly.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061203: Ziehm Vision R Digital Mobile Imaging System, Ziehm Imaging, Inc. (2006) Summary page 1.
- K073346: Ziehm Vision 2, Ziehm Imaging, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K203428: Ziehm Vision RFD (2021), 3 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-2641-2016: 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-0568-2014: 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 RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

Source page: https://510kreport.com/device/K083545
Methodology: https://510kreport.com/methodology