510(k) K232032 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROBEAT-FR
| Applicant | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, Kashiwa-Shi, JP |
| Decision | Substantially Equivalent, Jan 12, 2024 |
| Received | Jul 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2026 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Brand Name: Hitachi Proton Beam Therapy System
Ref: PROBEAT-FR Open, Classified |
LHN | None listed |
| Sep 12, 2024 | Hitachi America, Ltd., Particle Therapy Division Brand Name: PROBEAT
Product Name: PROBEAT-FR
Model/Catalog Number: N/A
Software Version: N/A
Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proto Open, Classified |
LHN | None listed |
| Sep 12, 2024 | Hitachi America, Ltd., Particle Therapy Division Brand Name: PROBEAT
Product Name: PROBEAT-CR
Model/Catalog Number: N/A
Software Version: N/A
Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proto Open, Classified |
LHN | None listed |
| Sep 12, 2024 | Hitachi America, Ltd., Particle Therapy Division Brand Name: PROBEAT
Product Name: PROBEAT-V
Model/Catalog Number: N/A
Software Version: N/A
Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton Open, Classified |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.