PROBEAT-FR
FDA 510(k) clearance K232032 · decided 2024-01-12
Clearance details
- K-number
- K232032
- Device name
- PROBEAT-FR
- Applicant
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Decision
- Substantially Equivalent
- Date received
- 2023-07-07
- Decision date
- 2024-01-12
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- LHN
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kashiwa-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROBEAT-CR (K260174) | Hitachi High-Tech Corp. | 2026-06-11 |
| ProBeam 360 Proton Therapy System v3.0 (K252815) | Varian Medical Systems, Inc. | 2026-04-23 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K253406) | Mevion Medical Systems, Inc. | 2026-03-25 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K250986) | Mevion Medical Systems, Inc. | 2025-09-12 |
| eMotus Respiratory Motion Management System (K243900) | Empnia, Inc. | 2025-06-27 |
| P-Cure Proton Therapy System (PPTS) (K242418) | P-Cure, Ltd. | 2025-05-12 |
| ProBeam 360° Proton Therapy System v2.0 (Multiroom) (K231863) | Varian Medical Systems, Inc. | 2023-10-06 |
| P-Cure Proton Beam Therapy System (K221996) | P-Cure, Ltd. | 2023-03-20 |
| Small Field Applicator (K220883) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 |
| ProBeam 360° Proton Therapy System (K221791) | Varian Medical Systems, Inc. | 2022-12-01 |
| myQA iON (K201798) | Iba Dosimetry GmbH | 2020-07-17 |
| PROBEAT-CR (K201042) | Hitachi , Ltd. | 2020-07-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR recall (Z-1429-2026) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2026-02-20 |
| Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N recall (Z-3125-2024) | Hitachi America, Ltd., Particle Therapy Division | 2024-09-12 |
| Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N recall (Z-3126-2024) | Hitachi America, Ltd., Particle Therapy Division | 2024-09-12 |
| Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/ recall (Z-3127-2024) | Hitachi America, Ltd., Particle Therapy Division | 2024-09-12 |