510(k) K161163 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
| Applicant | Hitachi , Ltd., Tokyo, JP |
| Decision | Substantially Equivalent, Jul 13, 2016 |
| Received | Apr 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161163
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.