510(k) K131777 ยท IWB System, Radiation Therapy, Radionuclide
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
| Applicant | Hyper Technology, Inc., Shanghai, CN |
| Decision | Substantially Equivalent, Feb 28, 2014 |
| Received | Jun 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131777
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.