K260308
- 510(k) number
- K260308
- Device name
- TrueFit Bolus
- Applicant
- Adaptiiv Medical Technologies, Inc. CA
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2026-02-19
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260308.pdf
Official FDA record: K260308
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.