510(k) K180599

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

K180599 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics for the device "Venue". The FDA issued a decision of Substantially Equivalent on May 2, 2018. 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.