CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC

CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC is an FDA 510(k)-cleared medical device (K896609) manufactured by Philips Medical Systems North America, 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 January 30, 1990. Regulation: 8.