K252863
- 510(k) number
- K252863
- Device name
- ClearCalc Model RADCA V2.6
- Applicant
- Radformation, Inc. NY · US
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2025-12-19
- Date received
- 2025-09-09
- 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: K252863.pdf
Official FDA record: K252863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.