IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM

IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM is an FDA 510(k)-cleared medical device (K992467) manufactured by Dba Systems, 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 9, 2000. Regulation: 8.