510(k) K073346 ยท JAK System, X-Ray, Tomography, Computed
ZIEHM VISION 2
| Applicant | Ziehm Imaging, Inc., Riverside CA, US |
| Decision | Substantially Equivalent, Mar 21, 2008 |
| Received | Nov 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision system, x-ray, tomography, computed. Open, Classified |
JAK | None listed |
| Apr 15, 2016 | Ziehm Imaging Inc Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Terminated |
JAA | None listed |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System.
Mobile Fluoroscopic Imaging Terminated |
OWB | None listed |
| Dec 24, 2013 | Ziehm Imaging Inc Ziehm Vision(2) 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.