# K161976: Ziehm Solo FD

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging GmbH
- Decided: Oct 6, 2016 after 80 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: 5 generations back to K003266 (2000). 9 ancestors in all.
8 later devices descend from it; 2 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092438: Ziehm Solo, Ziehm Imaging, Inc. (2009) Summary page 5.
- K073346: Ziehm Vision 2, Ziehm Imaging, Inc. (2008) Summary page 5.

## Most influential descendants
- K183220: OrthoScan TAU Mini C-Arm (2019), 4 descendants of its own
- K213113: Orthoscan Tau Mini C-Arm (2021), 3 descendants of its own
- K243452: Orthoscan VERSA Mini C-Arm (2025), 2 descendants of its own
- K231669: Ziehm Solo FD (2023), 2 descendants of its own
- K250587: Orthoscan TAU Mini C-Arm (2025), 1 descendant of its own

## Recalls of this device
- Feb 23, 2017 · Class II · Z-1893-2017: During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

## Indications for use
The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. 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. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. 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/K161976
Methodology: https://510kreport.com/methodology