K243057
- 510(k) number
- K243057
- Device name
- TrueFit Bolus; TrueFlex Bolus
- Applicant
- Adaptiiv Medical Technologies, Inc. CA
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2024-10-23
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243057.pdf
Official FDA record: K243057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.