510(k) K260479 · LLZ System, Image Processing, Radiological
TheraSphere 360 Y-90 Management Platform
| Applicant | Boston Scientific Corporation, Marborough MA, US |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Feb 13, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2026 | Boston Scientific Corporation Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.