K253025
- 510(k) number
- K253025
- Device name
- Ricoh 3D for Healthcare Bolus
- Applicant
- Ricoh 3D For Healthcare, LLC OH · US
- Product code
- IXI — Block, Beam-Shaping, Radiation Therapy
- Decision date
- 2026-04-06
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253025.pdf
Official FDA record: K253025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.