510(k) K915201

CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO by Bennett X-Ray Corp. — Product Code IZH

K915201 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO". The FDA issued a decision of Substantially Equivalent on July 28, 1992. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.