510(k) K133686

21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) by Jvckenwood Corporation — Product Code LLZ

K133686 is an FDA 510(k) premarket notification submitted by Jvckenwood Corporation for the device "21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)". The FDA issued a decision of Substantially Equivalent on January 6, 2014. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Jvckenwood Corporation has at least 10 other 510(k) clearances on record.