# K132904: Ziehm Vision RFD

- Pathway: 510(k) (Special)
- Applicant: Ziehm Imaging GmbH
- Decided: Dec 5, 2013 after 80 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003266 (2000). 12 ancestors in all.
16 later devices descend from it; 3 cite 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)
- K083545: Ziehm Vision RFD, Ziehm Imaging, Inc. (2009) Summary page 2.

## Most influential descendants
- 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
- K243303: Ziehm Vision RFD 3D (2025), 2 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-2640-2016: 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.

## 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 include 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, ields. 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. The system is not intended for use near MRI systems.

Source page: https://510kreport.com/device/K132904
Methodology: https://510kreport.com/methodology