510(k) K252718

Lunar Astra by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code KGI

K252718 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "Lunar Astra". The FDA issued a decision of Substantially Equivalent on April 20, 2026. 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.