TheraSphere 360™ Y-90 Management Platform

TheraSphere 360™ Y-90 Management Platform is an FDA 510(k)-cleared medical device (K252547) manufactured by Boston Scientific Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2025. Regulation: 8.