ISA-21 INTERVENTIONAL SPINE ARRAY COIL

ISA-21 INTERVENTIONAL SPINE ARRAY COIL is an FDA 510(k)-cleared medical device (K021631) 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 August 12, 2002. Regulation: 8.