510(k) K012490 ยท OWB Interventional Fluoroscopic X-Ray System
ORION DIGITAL IMAGING SYSTEM
| Applicant | Infimed, Inc., Liverpool NY, US |
| Decision | Substantially Equivalent, Feb 12, 2002 |
| Received | Aug 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012490
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.