510(k) K243794

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

K243794 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 February 6, 2025. 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 at least 10 other 510(k) clearances on record.