510(k) K092438 ยท OWB Interventional Fluoroscopic X-Ray System
ZIEHM SOLO
| Applicant | Ziehm Imaging, Inc., Riverside CA, US |
| Decision | Substantially Equivalent, Dec 23, 2009 |
| Received | Aug 7, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Solo. Digital Mobile C-arm Open, Classified |
OWB | None listed |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
OWB | None listed |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | None listed |
| Apr 16, 2012 | Ziehm Imaging Inc Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.