510(k) K102533 ยท IWB System, Radiation Therapy, Radionuclide
ROTATING GAMMA SYSTEM INFINI (INFINI)
| Applicant | Masep Medical Science & Tech.Development (Shenzhen, Great Neck NY, US |
| Decision | Substantially Equivalent, Mar 22, 2011 |
| Received | Sep 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102533
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.