510(k) K181485

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System by Philips Ultrasound, Inc. — Product Code IYN

K181485 is an FDA 510(k) premarket notification submitted by Philips Ultrasound, Inc. for the device "EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Jul 27, 2018. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Philips Ultrasound, Inc. has 76 other 510(k) clearances on record.