# K190497: Ziehm 8000

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging GmbH
- Decided: Nov 20, 2019 after 265 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: 1 generation back to K051064 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051064: Ziehm Quantum, Ziehm Imaging, Inc. (2005) Summary page 5.

## Indications for use
The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures or guidance procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, neurologic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

Source page: https://510kreport.com/device/K190497
Methodology: https://510kreport.com/methodology