Cleared Traditional

TheraSphere 360? Y-90 Management Platform

K252547 · Boston Scientific Corporation · Radiology
Oct 2025
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K252547 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 (Malborough, US). The FDA issued a Cleared decision on October 28, 2025, 77 days after receiving the submission on August 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K252547 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2025
Decision Date October 28, 2025
Days to Decision 77 days
Submission Type Traditional
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