510(k) Report

Devices descending from K941362

22 later devices reach Bone Mineral Densitometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060111Iva (Mxa II Software Option)Hologic, Inc.20066—
+1K023398Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryHologic, Inc.2002191
+2K130277Single Energy (SE) Femur ExamsHologic, Inc.20135—
+2K072847Apex 2.0 Software for QDR X-Ray Bone DensitometersHologic, Inc.200809
+2K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc.200613—
+2K042480Infant Whole Body Software Option for QDR DensitometersHologic, Inc.20041—
+2K041266Pediatric Reference DatabaseHologic, Inc.200401
+2K033224Hologic QDR Explorer X-Ray Bone Densitometer, Model ExplorerHologic, Inc.20031—
+3K2208223D-Shaper3D-Shaper Medical S.L20221—
+3K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+3K133664Encore Version 16 Software for GE Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn201401
+3K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia20087—
+3K082402Osdx Hip BMD SystemImaging Therapeutics, Inc.20086—
+4K2510223D-Shaper3D-Shaper Medical S.L20250—
+4K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+4K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—
+4K121716TBS InsightMedimaps Group SA20125—
+4K113725VirtuostO.N. Diagnostics20121—
+5K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+5K220402VirtuOstO.N. Diagnostics20230—
+5K152299TBS iNsightMedimaps Group SA201642
+6K243218TBS iNsight (V4)Medimaps Group SA20250—