510(k) K201042 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROBEAT-CR
| Applicant | Hitachi , Ltd., Kashiwa-Shi, JP |
| Decision | Substantially Equivalent, Jul 13, 2020 |
| Received | Apr 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2026 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Brand Name: Hitachi Proton Beam Therapy
REF: PROBEAT-CR Open, Classified |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.