
Hologic, Inc.
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R2 DIGITALNOW HD(DIGITALNOW HD) is an FDA 510(k)-cleared medical device (K091368) manufactured by Hologic, 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 June 3, 2009. Regulation: 8.