510(k) K210438

Versana Premier by GE Medical Systems Ultrasound And Primary Care Diagnostics — Product Code IYN

K210438 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics for the device "Versana Premier". The FDA issued a decision of Substantially Equivalent on Sep 10, 2021. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. GE Medical Systems Ultrasound And Primary Care Diagnostics has 82 other 510(k) clearances on record.