# K193230: Ziehm Vision FD

- Pathway: 510(k) (Special)
- Applicant: Ziehm Imaging GmbH
- Decided: Dec 20, 2019 after 25 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: 2 generations back to K011292 (2001). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061534: Ziehm Vision FD Digital Mobile Imaging System, Ziehm Imaging, Inc. (2006) Summary page 5.

## Most influential descendants
- K231700: Ziehm Vision FD (2023), 2 descendants of its own
- K240020: Ziehm Vision FD (2024), 1 descendant of its own
- K243735: Ziehm Vision FD (2025), 0 descendants of its own
- K212956: FDR Cross (DR-XD 3000) (2021), 0 descendants of its own

## Indications for use
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It 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. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

Source page: https://510kreport.com/device/K193230
Methodology: https://510kreport.com/methodology