510(k) K100691 ยท IYE Accelerator, Linear, Medical
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
| Applicant | Bionix Development Corp., Toledo OH, US |
| Decision | Substantially Equivalent, May 11, 2010 |
| Received | Mar 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100691
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.