510(k) K202216

EPIQ Series Diagnostic Ultrasound Systems by Philips Ultrasound, Inc. — Product Code IYN

K202216 is an FDA 510(k) premarket notification submitted by Philips Ultrasound, Inc. for the device "EPIQ Series Diagnostic Ultrasound Systems". The FDA issued a decision of Substantially Equivalent on Sep 2, 2020. 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.