510(k) Report

Devices descending from K890121

18 later devices reach Modified DPX Bone Densitometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961007Expert Spine Morphotietry ReferenceLunar Corp.199617—
+2K011917Advanced Hip Assessment SoftwareGe Lunar Corp.200116—
+3K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+3K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia20087—
+3K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia20070—
+3K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc.200613—
+3K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia200511
+4K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+4K2208223D-Shaper3D-Shaper Medical S.L20221—
+4K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+4K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—
+4K113725VirtuostO.N. Diagnostics20121—
+4K082402Osdx Hip BMD SystemImaging Therapeutics, Inc.20086—
+5K2510223D-Shaper3D-Shaper Medical S.L20250—
+5K220402VirtuOstO.N. Diagnostics20230—
+5K121716TBS InsightMedimaps Group SA20125—
+6K152299TBS iNsightMedimaps Group SA201642
+7K243218TBS iNsight (V4)Medimaps Group SA20250—