AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS

AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS is an FDA 510(k)-cleared medical device (K930282) manufactured by Elscint, 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 August 22, 1993. Regulation: 8.