SONOGRAF ULTRASOUND B-SCANNING SYSTEM

SONOGRAF ULTRASOUND B-SCANNING SYSTEM is an FDA 510(k)-cleared medical device (K781079) manufactured by Ohio Nuclear, 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 16, 1978. Regulation: 8.