1.5T and 3.0T 16 CH GE Shoulder Coils

1.5T and 3.0T 16 CH GE Shoulder Coils is an FDA 510(k)-cleared medical device (K162001) manufactured by Invivo Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2016. Regulation: 8.