K232032
- 510(k) number
- K232032
- Device name
- PROBEAT-FR
- Applicant
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha JP
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2024-01-12
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232032.pdf
Official FDA record: K232032
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.