Cleared Special

TheraSphere 360? Y-90 Management Platform

K260479 · Boston Scientific Corporation · Radiology
Mar 2026
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K260479 is an FDA 510(k) clearance for the TheraSphere 360? Y-90 Management Platform, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on March 13, 2026, 28 days after receiving the submission on February 13, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K260479 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2026
Decision Date March 13, 2026
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050