K262462
- 510(k) number
- K262462
- Device name
- TheraSphere 360 Y-90 Management Platform
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-07-24
- Date received
- 2026-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K262462.pdf
Official FDA record: K262462
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.