510(k) K171049 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Real Time Image Gating System for Proton Beam Therapy Systems
| Applicant | Hitachi, Ltd. Healthcare, Tokyo, JP |
| Decision | Substantially Equivalent, Dec 26, 2017 |
| Received | Apr 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171049
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.