510(k) K160063 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
McLaren Proton Therapy System
| Applicant | Mclaren Health Care Corporation, Flint MI, US |
| Decision | Substantially Equivalent, Feb 25, 2016 |
| Received | Jan 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160063
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.