510(k) K191821 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Blue Phantom PT
| Applicant | Iba Dosimetry GmbH, Schwarzenbruck, DE |
| Decision | Substantially Equivalent, Jan 23, 2020 |
| Received | Jul 8, 2019 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K191821
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.