
Toshiba America Mri, Inc.
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OPART, MODEL MRT-600 is an FDA 510(k)-cleared medical device (K002522) manufactured by Toshiba America Mri, 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 October 24, 2000. Regulation: 8.