Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
JapanFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 22 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha makes
The company manufactures radiation therapy devices, including small field applicators for precise targeted treatment and the PROBEAT-FR, a specialized applicator designed for brachytherapy procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Small Field Applicator Ref K220883
Regimes: 510(k) Registry: 510(k)Probeat-Fr Ref K232032
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, initiated on 2026-02-06. By recorded status: 2 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 2
2026
- 6 Feb 2026 Z-1429-2026 Class II Ongoing Software anomaly in the patient positioning system may result in positional discrepancy.
- 6 Feb 2026 Z-1430-2026 Class II Ongoing Software anomaly in the patient positioning system may result in positional discrepancy.
Frequently asked questions
How many devices does Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha have in the registry?
The registry currently lists 2 devices for Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha's devices?
Among its 2 most recently registered devices, Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha has devices listed in FDA 510(k) (2 devices).
What risk classes do Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha?
FDA recall records list 2 recalls initiated by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, the most recent initiated on 6 Feb 2026. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha in the registry?
The most recently registered devices listed for Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha include Small Field Applicator and PROBEAT-FR.