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KGI — Densitometer, Bone Class II

FDA Device Classification

Classification Details

Product Code
KGI
Device Class
Class II
Regulation Number
892.1170
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K2510223d-shaper medical s.l3D-SHAPERSeptember 5, 2025
K242295bunkerhill healthBunkerHill BMDApril 8, 2025
K243218medimaps groupTBS iNsight (V4)January 17, 2025
K220402o.n. diagnosticsVirtuOstMay 19, 2023
K2208223d-shaper medical s.l3D-SHAPERDecember 9, 2022
K213760heartlung corporationABMD SoftwareJuly 29, 2022
K191112ge medical systems ultrasound and primary care diagnosticsGEHC DXA Bone Densitometers with enCORE version 18September 19, 2019
K180782ge medical systems ultrasound and primary care diagnosticsAriaApril 20, 2018
K161682ge medical systems ultrasound and primary care diagnosticsGE Lunar DXA Bone Densitometers with enCORE version 17December 2, 2016
K152299medimaps groupTBS iNsightApril 29, 2016
K140342mindways softwareQCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCTAugust 29, 2014
K133664ge medical systems ultrasound and primary care diagnENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERSMay 15, 2014
K130277hologicSINGLE ENERGY (SE) FEMUR EXAMSMay 31, 2013
K121716medimaps groupTBS INSIGHTOctober 5, 2012
K113725o.n. diagnosticsVIRTUOSTSeptember 13, 2012
K113286ge medical systems lunarENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERSApril 27, 2012
K113616lone oak medical technologiesACCUDXA2April 27, 2012
K113356hologicHOLOGIC VISCERAL FAT SOFTWAREMarch 6, 2012
K103730ge medical systems ultrasound and primary care diaGE LUNAR VISCERAL FAT SOFTWAREMay 6, 2011
K103265hologicNHANES WHOLE BODY DXA REFERENCE DATABASEMarch 16, 2011