510(k) K122644 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, May 16, 2013 |
| Received | Aug 29, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Siemens Medical Solutions USA, Inc Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.