MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL

MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL is an FDA 510(k)-cleared medical device (K952944) 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 August 22, 1995. Regulation: 8.