Densitometer, Bone

Product Code: KGI

Radiology X-Ray Bone Densitometers

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31]

Code of Federal Regulations: 892.1170


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as KGI

5367Densitometer, BoneBone Densitometer.

Total Product Life Cycle (TPLC) Devices

5367Densitometer, BoneBone Densitometer.

Pre-market Notifications for KGI

K2208223D-SHAPER3D-Shaper Medical S.L
K213760ABMD SoftwareHeartLung Corporation
K191112GEHC DXA Bone Densitometers With EnCORE Version 18GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics,LLC
K161682GE Lunar DXA Bone Densitometers With EnCORE Version 17GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
K152299TBS INsightMEDIMAPS GROUP SA
K140342QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCTMINDWAYS SOFTWARE, INC.
K133664ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERSGE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN
K130277SINGLE ENERGY (SE) FEMUR EXAMSHOLOGIC, INC.
K121716TBS INSIGHTMEDIMAPS GROUP SA
K113616ACCUDXA2LONE OAK MEDICAL TECHNOLOGIES, LLC
K113356HOLOGIC VISCERAL FAT SOFTWAREHOLOGIC, INC.
K113286ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERSGE MEDICAL SYSTEMS LUNAR
K103730GE LUNAR VISCERAL FAT SOFTWAREGE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
K103265NHANES WHOLE BODY DXA REFERENCE DATABASEHOLOGIC, INC.

Global Unique Device Identification Database

00866955000461Densitometer, Bone
00866955000454Densitometer, Bone
00866955000447Densitometer, Bone
00866955000430Densitometer, Bone
00866955000423Densitometer, Bone
00866955000416Densitometer, Bone
00866955000409Densitometer, Bone
00860000233101Densitometer, Bone
04260491560025Densitometer, Bone
04260491560018Densitometer, Bone
B214OSTBSI303Densitometer, Bone
B214OSTBSI0Densitometer, Bone
B052QCTPROM4ASH0Densitometer, Bone
B052QCTPROM3SSH0Densitometer, Bone
B052QCTPROM3SS0Densitometer, Bone

Maude Adverse Events

HORIZONHOLOGIC, INC2018-01-19
HORIZONHOLOGIC, INC.2018-01-10
DISCOVERYHOLOGIC, INC.2018-01-10
DISCOVERYHOLOGIC, INC2018-01-10
DISCOVERYHOLOGIC, INC.2018-01-02
HORIZONHOLOGIC, INC.2018-01-02
HORIZONHOLOGIC, INC.2017-12-28
QDRDENSITOMETER, BONEHOLOGIC, INC.2017-12-22
HORIZONHOLOGIC, INC.2017-12-14
DISCOVERYHOLOGIC, INC.2017-12-13
HORIZONHOLOGIC, INC.2017-12-12
DISCOVERYHOLOGIC, INC.2017-12-08
DISCOVERYHOLOGIC, INC.2017-12-07
DISCOVERYHOLOGIC, INC.2017-12-05
HORIZONHOLOGIC, INC.2017-11-22
DISCOVERYHOLOGIC, INC.2017-11-22
HORIZONHOLOGIC, INC.2017-11-21
HORIZONHOLOGIC, INC.2017-11-20
DISCOVERYHOLOGIC, INC.2017-11-15
HORIZONHOLOGIC, INC.2017-11-07
DISCOVERYHOLOGIC, INC.2017-10-05
DISCOVERY DXAHOLOGIC, INC.2017-03-02
HOLOGIC DISCOVERYHOLOGIC INC2016-02-08
LUNAR PRODIGYDATEX-OHMEDA INC.2014-09-11
MINDWAYS QCT PROMINDWAYS SOFTWARE, INC.2014-04-08
LUNAR PRODIGYGE HEALTHCARE2013-12-10
PRODIGYGE HEALTHCARE2012-11-01
DISCOVERYHOLOGIC, INC.2011-10-21
ACHILLES EXPRESSGE MEDICAL SYSTEMS (CHINA) CO., LTD.2011-10-18
DPX BRAVOGE MEDICAL SYSTEMS (CHINA) CO. LTD.2011-07-28
GE LUNAR PRODIGY ADVANCEGE HEALTHCARE2011-06-09
HOLOGIC QDRHOLOGIC, INC.2011-01-18
PRODIGY ADVANCEGE LUNAR CORP.2009-08-12
OMNISENSE 7000PSUNLIGHT MEDICAL INC2009-06-13
DISCOVERYHOLOGIC, INC.2009-03-10
DISCOVERYHOLOGIC, INC.2008-12-10
QDR BONE DENSITOMETERHOLOGIC, INC.2008-07-01
BONE DENSITOMETERHOLOGIC, INC.2006-10-26
BONE DENSITOMETERHOLOGIC, INC.2006-09-26
SAHARA BONE DENSITOMETERHOLOGIC INC2002-05-29
DPX X-RAY BONE DENSITOMETERLUNAR CORP2001-04-03
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