510(k) Report

Devices descending from K082317

7 later devices reach GE Lunar Frax 10-Year Fracture Risk Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202514EchoS FamilyEcholight S.P.A20211—
+1K152299TBS iNsightMedimaps Group SA201642
+2K243218TBS iNsight (V4)Medimaps Group SA20250—
+2K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+2K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+3K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+3K2510223D-Shaper3D-Shaper Medical S.L20250—