PROBEAT-FR— 510(k) K232032
Substantially EquivalentHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
FDA 510(k) clearance K232032 for PROBEAT-FR, Substantially Equivalent on 2024-01-12. Applicant: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. Device class: 2.
Clearance details
- Applicant
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Product code
- Code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kashiwa-Shi, JP
Recent devices under product code LHN
view allMore clearances from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
view allRecalls naming K232032
K-number listed on FDA's recall record- Z-1429-2026 — Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- Z-3125-2024 — 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 proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
- Z-3126-2024 — 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 proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
- Z-3127-2024 — 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 beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232032.
Data sourced from openFDA. This site is unofficial and independent of the FDA.