510(k) K970647 ยท IWB System, Radiation Therapy, Radionuclide
OUR ROTATING GAMMA SYSTEM
| Applicant | Our Scientific Intl., Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, May 20, 1997 |
| Received | Feb 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970647
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.