510(k) K993598

MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 by Vidar Systems Corp. — Product Code LMA

K993598 is an FDA 510(k) premarket notification submitted by Vidar Systems Corp. for the device "MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205". The FDA issued a decision of Substantially Equivalent on January 20, 2000. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Vidar Systems Corp. has at least 10 other 510(k) clearances on record.