510(k) K160612 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Sumitomo Proton Therapy System
| Applicant | Sumitomo Heavy Industries, Ltd., Niihama, JP |
| Decision | Substantially Equivalent, Aug 17, 2016 |
| Received | Mar 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160612
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.