510(k) Report

Devices descending from K945668

7 later devices reach KXO-80G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060111Iva (Mxa II Software Option)Hologic, Inc.20066—
+2K130277Single Energy (SE) Femur ExamsHologic, Inc.20135—
+3K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201641
+4K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201921
+4K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20180—
+5K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+5K2510223D-Shaper3D-Shaper Medical S.L20250—