ULTRAMARK 1 ULTRASOUND SYSTEM

ULTRAMARK 1 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K862681) manufactured by Advanced Technology Laboratories, 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 July 15, 1986. Regulation: 8.