510(k) Report

Devices descending from K061561

13 later devices reach Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2208223D-Shaper3D-Shaper Medical S.L20221—
+1K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia20087—
+1K082402Osdx Hip BMD SystemImaging Therapeutics, Inc.20086—
+2K2510223D-Shaper3D-Shaper Medical S.L20250—
+2K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+2K121716TBS InsightMedimaps Group SA20125—
+2K113725VirtuostO.N. Diagnostics20121—
+3K220402VirtuOstO.N. Diagnostics20230—
+3K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+3K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—
+3K152299TBS iNsightMedimaps Group SA201642
+4K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+4K243218TBS iNsight (V4)Medimaps Group SA20250—