Data / Medical devices / Japan / Hitachi High-Tech Corp., Kashiwanoha
Hitachi High-Tech Corp., Kashiwanoha: FDA-registered device maker in KASHIWA-SHI Chiba, Japan, 14 510(k) clearances
Hitachi High-Tech Corp., Kashiwanoha is registered with the FDA (registration 1000162206) in KASHIWA-SHI Chiba, Japan. It lists 2 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 11, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000162206
- Address
- 226-44-141-1, Wakashiba, KASHIWA-SHI Chiba, Japan, 277-0871
- Owner or operator
- HITACHI HIGH-TECH CORP. (9049564)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 17, 2026
- Registered through
- 2026
- Brand names listed
- EXTENDED RANGE SHIFTER FOR PROBEAT-V, MHI-TM2000 LINEAR ACCELERATOR SYSTEM, MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS, MHI-TM2000 Linear Accelerator System, VERO, Imavis, Mini Ridge Filter and auxiliary functions for PROBEAT-V, PROBEAT-CR, PROBEAT-FR, PROBEAT-V and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 11, 2026 | K260174 | PROBEAT-CR | LHN | Substantially Equivalent | Hitachi High-Tech Corp. | accessdata.fda.gov |
| January 12, 2024 | K232032 | PROBEAT-FR | LHN | Substantially Equivalent | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | accessdata.fda.gov |
| December 15, 2022 | K220883 | Small Field Applicator | LHN | Substantially Equivalent | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | accessdata.fda.gov |
| September 13, 2019 | K191801 | PROBEAT-CR | LHN | Substantially Equivalent | Hitachi , Ltd. | accessdata.fda.gov |
| August 15, 2018 | K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | LHN | Substantially Equivalent | Hitachi Ltd. Healthcare Hitachi Works | accessdata.fda.gov |
| December 26, 2017 | K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | LHN | Substantially Equivalent | Hitachi, Ltd. Healthcare | accessdata.fda.gov |
| July 13, 2016 | K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | LHN | Substantially Equivalent | Hitachi , Ltd. | accessdata.fda.gov |
| April 21, 2016 | K153614 | PROBEAT-V and accessories | LHN | Substantially Equivalent | Hitachi, Ltd., Health Care Company | accessdata.fda.gov |
| November 2, 2015 | K152592 | PROBEAT-V | LHN | Substantially Equivalent | Hitachi, Ltd., Health Care Company | accessdata.fda.gov |
| October 21, 2015 | K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | IYE | Substantially Equivalent | Mitsubishi Heavy Industries, Ltd. | accessdata.fda.gov |
| October 2, 2015 | K152207 | Extended Range Shifter for PROBEAT-V | LHN | Substantially Equivalent | Hitachi, Ltd., Health Care Company | accessdata.fda.gov |
| June 1, 2015 | K151132 | PROBEAT-V | LHN | Substantially Equivalent | Hitachi, Ltd., Health Care Company | accessdata.fda.gov |
| October 3, 2012 | K122450 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS | IYE | Substantially Equivalent | Mitsubishi Heavy Industries, Ltd. | accessdata.fda.gov |
| August 29, 2007 | K072047 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM | IYE | Substantially Equivalent | Mitsubishi Heavy Industries, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | 98330 | Class II | Ongoing | Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | Software anomaly in the patient positioning system may result in positional discrepancy. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, Radiation Therapy, Charged-Particle, Medical
Updated June 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.