510(k) K181934

Vivid T8, Vivid T9 by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code IYN

K181934 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "Vivid T8, Vivid T9". The FDA issued a decision of Substantially Equivalent on Nov 6, 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 & Primary Care Diagnostics, LLC has 82 other 510(k) clearances on record.