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Medical Advances, Inc.
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MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL is an FDA 510(k)-cleared medical device (K003144) manufactured by Medical Advances, 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 December 12, 2000. Regulation: 8.