510(k) K912250 ยท IWB System, Radiation Therapy, Radionuclide
ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
| Applicant | Theta Systems, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Nov 5, 1991 |
| Received | May 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912250
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.