510(k) K082773 ยท IYE Accelerator, Linear, Medical
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
| Applicant | Standard Imaging, Inc., Middleton WI, US |
| Decision | Substantially Equivalent, Nov 19, 2008 |
| Received | Sep 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082773
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.