Atlas FDA

KGI

147 FDA 510(k) clearances · Product code

120 daysmedian time to decision
374 days90th percentile
147clearances measured

FDA profile

Official device name
Densitometer, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1170
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 2 · 2009: 3 · 2011: 5 · 2017: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Lunar Astra (K252718)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2026-04-20
3D-SHAPER (K251022)3D-Shaper Medical S.L2025-09-05
BunkerHill BMD (K242295)BunkerHill Health2025-04-08
TBS iNsight (V4) (K243218)Medimaps Group SA2025-01-17
VirtuOst (K220402)O.N. Diagnostics2023-05-19
3D-SHAPER (K220822)3D-Shaper Medical S.L2022-12-09
ABMD Software (K213760)HeartLung Corporation2022-07-29
GEHC DXA Bone Densitometers with enCORE version 18 (K191112)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2019-09-19
Aria (K180782)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2018-04-20
GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016-12-02
TBS iNsight (K152299)Medimaps Group SA2016-04-29
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (K140342)Mindways Software, Inc.2014-08-29
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS (K133664)Ge Medical Systems Ultrasound & Primary Care Diagn2014-05-15
SINGLE ENERGY (SE) FEMUR EXAMS (K130277)Hologic, Inc.2013-05-31
TBS INSIGHT (K121716)Medimaps Group SA2012-10-05
VIRTUOST (K113725)O.N. Diagnostics2012-09-13
ACCUDXA2 (K113616)Lone Oak Medical Technologies, LLC2012-04-27
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS (K113286)Ge Medical Systems Lunar2012-04-27
HOLOGIC VISCERAL FAT SOFTWARE (K113356)Hologic, Inc.2012-03-06
GE LUNAR VISCERAL FAT SOFTWARE (K103730)Ge Medical Systems Ultrasound and Primary Care Dia2011-05-06
NHANES WHOLE BODY DXA REFERENCE DATABASE (K103265)Hologic, Inc.2011-03-16
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS (K091325)Cooper Surgical2009-06-29
GE LUNAR FEMUR STRENGTH SOFTWARE (K072664)Ge Medical Systems Ultrasound and Primary Care Dia2008-11-21
OSDX HIP BMD SYSTEM (K082402)Imaging Therapeutics, Inc.2008-10-16
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION (K082317)General Electric Co.2008-09-26
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION (K080711)Hologic, Inc.2008-09-02
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS (K072847)Hologic, Inc.2008-03-28
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT (K072439)Ge Medical Systems Ultrasound and Primary Care Dia2007-09-14
GE LUNAR BODY COMPOSITION SOFTWARE (K071570)Ge Medical Systems Lunar2007-06-27
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561)Hologic, Inc.2006-07-28
IVA (MXA II SOFTWARE OPTION) (K060111)Hologic, Inc.2006-04-24
LUNAR IDXA (K052581)Ge Medical Systems Ultrasound and Primary Care Dia2005-10-20
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS (K042480)Hologic, Inc.2004-10-29
PEDIATRIC REFERENCE DATABASE (K041266)Hologic, Inc.2004-08-11
DXL CALSCAN (K033550)Demetech AB2004-05-05
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER (K033224)Hologic, Inc.2003-11-05
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS (K031991)Image Analysis, Inc.2003-07-30
DPX SERIES BRAVO DUO BONE DENSITOMETER (K030962)Ge Lunar Corp.2003-07-25
CTXA HIP EXTENDED REFERENCE DATA (K030330)Mindways Software, Inc.2003-06-20
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE (K023554)Ge Lunar Corp.2002-12-20
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY (K023398)Hologic, Inc.2002-11-08
SECTRA OSTEOPOROSIS PACKAGE (K021527)Sectra-Imtec AB2002-06-07
DEXACARE G4 (K021331)Osteometer Meditech, Inc.2002-05-21
CTXA HIP; CTXA; QCT PRO CTXA HIP (K002113)Mindways Software, Inc.2001-12-04
ADVANCED HIP ASSESSMENT SOFTWARE (K011917)Ge Lunar Corp.2001-08-03
X-POSURE SYSTEM VERSION 2 MAMMO (K003656)Pronosco A/S2000-12-15
X-POSURE SYSTEM VERSION 2 RAD (K002500)Pronosco A/S2000-10-23
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER (K002711)Hologic, Inc.2000-09-28
PEDIATRIC REFERENCE DATA (K001812)Lunar Corp.2000-07-10
LUNAR REPORT GENERATOR II (K001756)Lunar Corp.2000-07-06
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY (K993176)Norland Medical Systems, Inc.2000-06-20
MODIFICATION TO ACCUDEXA BONE DENSITOMETER (K001429)Schick Technologies, Inc.2000-05-26
APOLLO MULTI-RACIAL REFERENCE POPULATION (K993337)Norland Medical Systems, Inc.2000-05-16
METRISCAN BONE DENSITY SYSTEM (K000162)Alara, Inc.2000-05-12
PRODIGY LATERAL VIEW SOFTWARE (K000826)Lunar Corp.2000-04-14
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 (K992125)Norland Medical Systems, Inc.1999-11-22
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992775)Hologic, Inc.1999-10-01
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992677)Hologic, Inc.1999-09-03
QCT BONE MINERAL ANALYSIS SOFTWARE (K992246)Image Analysis, Inc.1999-09-03
OSTEOGRAM BONE DENSITOMETER (K984285)Compumed, Inc.1999-05-19
PRONOSCO X-POSURE SYSTEM (K984178)Torsana Osteoporosis Diagnostics A/S1999-02-18
ORCA-DX BONE DENSITOMETER (K983724)Lunar Corp.1998-12-08
PRODIGY TOTAL BODY SOFTWARE (K983564)Lunar Corp.1998-12-08
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS (K983262)Lunar Corp.1998-11-18
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS (K983271)Lunar Corp.1998-11-18
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER (K983269)Lunar Corp.1998-11-18
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K983028)Hologic, Inc.1998-11-13
XCT 2000 L PQCT BONE DENSITOMETER (K983273)Medical Systems, Inc.1998-10-29
DPX-RX BONE DENSITOMETER (K982267)Lunar Corp.1998-08-18
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS (K980569)Norland Corp.1998-06-12
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER (K980289)Norland Corp.1998-06-12
ACCUDEXA BONE DENSITOMETER (K981124)Schick Technologies, Inc.1998-06-04
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER (K980125)Norland Corp.1998-05-20
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE (K974437)Lunar Corp.1998-02-13
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS (K973459)Norland Corp.1998-02-13
NORLAND MODEL PDEXA BONE DENSITOMETER (K973104)Norland Corp.1998-01-29
ACCUDEXA BONE DENSITOMETER (K971735)Schick Technologies, Inc.1997-12-02
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE (K972517)Lunar Corp.1997-11-18
APOLLO (K972882)Norland Corp.1997-10-31
DTX-200 BONE DENSITOMETER (K964562)Osteometer Meditech A/S1997-08-22
PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM (K972053)Lunar Corp.1997-08-08
DTX-100 BONE DENSITOMETER (K963789)Osteometer Meditech A/S1997-07-14
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS (K961787)Hologic, Inc.1997-06-13
PIXI BONE DENSITOMETER (K970224)Lunar Corp.1997-04-16
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS (K964307)Lunar Corp.1997-04-16
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS (K963363)Hologic, Inc.1996-11-22
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE (K964263)Lunar Corp.1996-11-07
EXPERT SPINE MORPHOTIETRY REFERENCE (K961007)Lunar Corp.1996-07-25
DTX-200 BONE DENSITOMETER (K961011)Shotwell & Carr, Inc.1996-07-05
LUNAR REPORT GENERATOR (K961944)Lunar Corp.1996-07-03
LUNAR DPX DENSITOMETER (K953032)Lunar Corp.1995-10-23
BONE MINERAL DENSITOMETER (K941362)Hologic, Inc.1995-08-30
QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 (K952060)Image Analysis, Inc.1995-06-05
EXPERT MORPHOMERTY SOFTWARD (K950611)Lunar Corp.1995-05-24
QCT-BONE MINERAL ANALYSIS SOFTWARE (K941127)Image Analysis, Inc.1995-05-11
QCT-BONE MINERAL ANALYSIS PHANTOM (K941126)Image Analysis, Inc.1995-05-03
LUNAR EXPERT (K945526)Lunar Corp.1995-04-25
MODEL PDEXA BONE DENSITOMETER (K931996)Norland Corp.1995-02-01
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER (K943505)Hologic, Inc.1995-01-20
THE OSTEOREPORT (K934040)Woodson and Associates, LLC1994-09-26
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