510(k) K211597

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System by Philips Medical Systems — Product Code IYN

K211597 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on September 8, 2021. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Philips Medical Systems has at least 10 other 510(k) clearances on record.