AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN

AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN is an FDA 510(k)-cleared medical device (K932403) manufactured by Medrad, 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 February 23, 1994. Regulation: 8.