510(k) K042793 ยท OWB Interventional Fluoroscopic X-Ray System
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
| Applicant | Siemens Medi Cal Solutions, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Oct 7, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2006 | Siemens Medical Solutions USA, Inc Arcadis Orbic Mobile X-Ray System Terminated |
JAK | None listed |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Arcadis Varic Mobile X-Ray System Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.