510(k) K233788

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

K233788 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 13, 2024. 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.