510(k) K191521 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Radiance 330 Proton Beam Therapy System
| Applicant | Protom International Holding Corporation, Wakefield MA, US |
| Decision | Substantially Equivalent, Sep 27, 2019 |
| Received | Jun 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191521
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.