510(k) K152207 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Extended Range Shifter for PROBEAT-V
| Applicant | Hitachi, Ltd., Health Care Company, Tokyo, JP |
| Decision | Substantially Equivalent, Oct 2, 2015 |
| Received | Aug 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152207
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.