510(k) Report

Devices descending from K113286

5 later devices reach Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+2K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+2K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—
+3K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+3K2510223D-Shaper3D-Shaper Medical S.L20250—