CYTOGUIDE STEREOTATIC BIOPSY SYSTEM

CYTOGUIDE STEREOTATIC BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K933430) manufactured by Gold Coast Imaging, 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 September 21, 1994. Regulation: 8.