K240671
- 510(k) number
- K240671
- Device name
- XBeam (v2)
- Applicant
- Xstrahl, Ltd. GB
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2024-12-04
- Date received
- 2024-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240671.pdf
Official FDA record: K240671
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.