ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM

ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K936067) manufactured by Atlantis Diagnostics Intl., 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 October 26, 1995. Regulation: 8.