Hitachi High-Tech America, Inc. Radiation Therapy Division
Santa Clara, CA, US
HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION appears in FDA device records in Santa Clara, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Hitachi High-Tech America, Inc. Radiation Therapy Division carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Hitachi America, Ltd., Particle Therapy Divisionenforcement report, recall
- Hitachi America, Ltd., Power Systems Divisionenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003993895 | 3003993895 | HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION | 2535 Augustine Dr, Santa Clara, CA 95054 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number. | Class II | Open, Classified | |
| 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 | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number. | Class II | Open, Classified | |
| 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 | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number. | Class II | Open, Classified | |
| Z-1892-2019 | PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. | There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems. | Class II | Terminated | |
| Z-1838-2015 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain