510(k) K926575

MAMMOTEST PRODUCT, MODIFICATION by Fischer Imaging Corp. — Product Code EHD

K926575 is an FDA 510(k) premarket notification submitted by Fischer Imaging Corp. for the device "MAMMOTEST PRODUCT, MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 30, 1993. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Fischer Imaging Corp. has at least 10 other 510(k) clearances on record.