510(k) K191112

GEHC DXA Bone Densitometers with enCORE version 18 by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code KGI

K191112 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "GEHC DXA Bone Densitometers with enCORE version 18". The FDA issued a decision of Substantially Equivalent on September 19, 2019. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has at least 10 other 510(k) clearances on record.