# K231701: Ziehm Vision RFD 3D

- Pathway: 510(k) (Special)
- Applicant: Ziehm Imaging GmbH
- Decided: Jul 10, 2023 after 28 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 8 generations back to K003266 (2000). 15 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202360: Ziehm Vision RFD 3D, Ziehm Imaging GmbH (2020) Summary page 4.

## Most influential descendants
- K243303: Ziehm Vision RFD 3D (2025), 2 descendants of its own
- K253296: Digital C-ARM with 3D (2026), 0 descendants of its own
- K252735: C-beam (2026), 0 descendants of its own

## Recalls of this device
- Aug 8, 2024 · Class II · Z-0579-2025: 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

## Indications for use
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C- arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome. 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/K231701
Methodology: https://510kreport.com/methodology