510(k) K163120

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

K163120 is an FDA 510(k) premarket notification submitted by Philips Ultrasound, Inc. for the device "EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Jan 10, 2017. 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.