
Mri Devices Corp.
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IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K003899) manufactured by Mri Devices Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2001. Regulation: 8.