510(k) K162065

Ultrasound System SONIMAGE HS1 by Konica Minolta, Inc. — Product Code IYN

K162065 is an FDA 510(k) premarket notification submitted by Konica Minolta, Inc. for the device "Ultrasound System SONIMAGE HS1". The FDA issued a decision of Substantially Equivalent on October 19, 2016. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Konica Minolta, Inc. has at least 10 other 510(k) clearances on record.