510(k) Report

Devices descending from K060111

6 later devices reach Iva (Mxa II Software Option) through their predicates, nearest generation first.

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