510(k) K152577

ULTRASOUND SYSTEM SONIMAGE HS 1 by Konica Minolta, Inc. — Product Code IYN

K152577 is an FDA 510(k) premarket notification submitted by Konica Minolta, Inc. for the device "ULTRASOUND SYSTEM SONIMAGE HS 1". The FDA issued a decision of Substantially Equivalent on October 8, 2015. 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.