
Isoray, Inc.
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CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE is an FDA 510(k)-cleared medical device (K062384) manufactured by Isoray, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2006. Regulation: 8.