510(k) K083545 ยท OWB Interventional Fluoroscopic X-Ray System
ZIEHM VISION RFD
| Applicant | Ziehm Imaging, Inc., Riverside CA, US |
| Decision | Substantially Equivalent, May 15, 2009 |
| Received | Nov 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
OWB | None listed |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision RFD 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.