K260174
- 510(k) number
- K260174
- Device name
- PROBEAT-CR
- Applicant
- Hitachi High-Tech Corp. JP
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2026-06-11
- Date received
- 2026-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260174.pdf
Official FDA record: K260174
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.