ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)

ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) is an FDA 510(k)-cleared medical device (K961073) 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 February 18, 1997. Regulation: 8.