510(k) Report

Devices descending from K983271

8 later devices reach Fracture Risk Assessment Option for DPX Series Bone Densitometers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co.20087—
+2K202514EchoS FamilyEcholight S.P.A20211—
+2K152299TBS iNsightMedimaps Group SA201642
+3K243218TBS iNsight (V4)Medimaps Group SA20250—
+3K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+3K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+4K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+4K2510223D-Shaper3D-Shaper Medical S.L20250—