510(k) K060314 ยท IWB System, Radiation Therapy, Radionuclide
ROTATING GAMMA SYSTEM. GAMMA ART-6000
| Applicant | American Radiosurgery, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Feb 8, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060314
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.