# K092438: Ziehm Solo

- Pathway: 510(k) (Traditional)
- Applicant: Ziehm Imaging, Inc.
- Decided: Dec 23, 2009 after 138 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003266 (2000). 8 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K073346: Ziehm Vision 2, Ziehm Imaging, Inc. (2008) Summary page 1.

## Most influential descendants
- K161976: Ziehm Solo FD (2016), 8 descendants of its own
- 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

## Recalls of this device
- Aug 8, 2024 · Class II · Z-0573-2025: 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
- Apr 15, 2016 · Class II · Z-2643-2016: 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.
- Nov 21, 2013 · Class II · Z-0563-2014: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
- Apr 29, 2011 · Not classified · Z-1430-2012: On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional con

## Indications for use
The Ziehm Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care,, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.

Source page: https://510kreport.com/device/K092438
Methodology: https://510kreport.com/methodology