510(k) K033347 ยท IYE Accelerator, Linear, Medical
MODIFICATION TO: HI-ART SYSTEM
| Applicant | Tomotherapy Incorporated, Madison WI, US |
| Decision | Substantially Equivalent, Nov 12, 2003 |
| Received | Oct 20, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033347
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.