510(k) K181676 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mini Ridge Filter and auxiliary functions for PROBEAT-V
| Applicant | Hitachi Ltd. Healthcare Hitachi Works, Hitachi, JP |
| Decision | Substantially Equivalent, Aug 15, 2018 |
| Received | Jun 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181676
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.