Siemens 3.0 Blanket Array Coil

Siemens 3.0 Blanket Array Coil is an FDA 510(k)-cleared medical device (K142755) manufactured by Resonance Innovations, LLC. 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 22, 2014. Regulation: 8.