510(k) K253595

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

K253595 is an FDA 510(k) premarket notification submitted by Philips Ultrasound, LLC for the device "EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Mar 27, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Philips Ultrasound, LLC has 77 other 510(k) clearances on record.