510(k) K102771

BIOPSY HANDY, MRI BIOPSY HANDY by Somatex Medical Technologies GmbH — Product Code KNW

K102771 is an FDA 510(k) premarket notification submitted by Somatex Medical Technologies GmbH for the device "BIOPSY HANDY, MRI BIOPSY HANDY". The FDA issued a decision of Substantially Equivalent on June 24, 2011. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Somatex Medical Technologies GmbH has at least 6 other 510(k) clearances on record.