510(k) Report

Devices descending from K935454

17 later devices reach DPX Tissue Quantification Output through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983564Prodigy Total Body SoftwareLunar Corp.19983—
+1K973459Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp.199812—
+1K965226Expert-XL Total Body Acquisition and Analysis SoftwareLunar Corp.19970—
+2K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia20070—
+2K071570GE Lunar Body Composition SoftwareGe Medical Systems Lunar200710—
+2K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia200511
+2K992125XR 46 Dxa (Central) Bone Densitometer, Model XR 46Norland Medical Systems, Inc.199901
+3K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+3K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+3K113286Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar20125—
+3K103730GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia20111—
+3K103265Nhanes Whole Body Dxa Reference DatabaseHologic, Inc.20111—
+3K091325Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone DensitometersCooper Surgical20090—
+4K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+4K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—
+4K113356Hologic Visceral Fat SoftwareHologic, Inc.20120—
+5K2510223D-Shaper3D-Shaper Medical S.L20250—