510(k) K970137 ยท IYE Accelerator, Linear, Medical
EXL-12SP,12DP,15DP,20DP LINAC
| Applicant | Mitsubishi Electronics America, Inc., Conshohocken PA, US |
| Decision | Substantially Equivalent, Apr 15, 1997 |
| Received | Jan 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970137
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.