Densitometer, Bone
Regulation 892.1170
2510(k)s in 12 months (148 all time)
0recalls in 12 months (26 all time)
21recalls that name a 510(k)
Top companies in KGI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K254072 | BoneVue Curvebeam AI / Curvebeam, LLC | KGI |
| Apr 20, 2026 | K252718 | Lunar Astra GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI |
| Sep 5, 2025 | K251022 | 3D-SHAPER 3D-Shaper Medical S.L, ES | KGI |
| Apr 8, 2025 | K242295 | BunkerHill BMD BunkerHill Health | KGI |
| Jan 17, 2025 | K243218 | TBS iNsight (V4) Medimaps Group SA, CH | KGI |
| May 19, 2023 | K220402 | VirtuOst O.N. Diagnostics | KGI |
| Dec 9, 2022 | K220822 | 3D-SHAPER 3D-Shaper Medical S.L, ES | KGI |
| Jul 29, 2022 | K213760 | ABMD Software HeartLung Corporation | KGI |
| Sep 19, 2019 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI |
| Apr 20, 2018 | K180782 | Aria GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI |
| Dec 2, 2016 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | KGI |
| Apr 29, 2016 | K152299 | TBS iNsight Medimaps Group SA, CH | KGI |
| Aug 29, 2014 | K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT Mindways Software, Inc. | KGI |
| May 15, 2014 | K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS Ge Medical Systems Ultrasound & Primary Care Diagn | KGI |
| May 31, 2013 | K130277 | SINGLE ENERGY (SE) FEMUR EXAMS Hologic, Inc. | KGI |
| Oct 5, 2012 | K121716 | TBS INSIGHT Medimaps Group SA, CH | KGI |
| Sep 13, 2012 | K113725 | VIRTUOST O.N. Diagnostics | KGI |
| Apr 27, 2012 | K113616 | ACCUDXA2 Lone Oak Medical Technologies, LLC | KGI |
| Apr 27, 2012 | K113286 | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS Ge Medical Systems Lunar | KGI |
| Mar 6, 2012 | K113356 | HOLOGIC VISCERAL FAT SOFTWARE Hologic, Inc. | KGI |
| May 6, 2011 | K103730 | GE LUNAR VISCERAL FAT SOFTWARE Ge Medical Systems Ultrasound and Primary Care Dia | KGI |
| Mar 16, 2011 | K103265 | NHANES WHOLE BODY DXA REFERENCE DATABASE Hologic, Inc. | KGI |
| Jun 29, 2009 | K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS Cooper Surgical | KGI |
| Nov 21, 2008 | K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE Ge Medical Systems Ultrasound and Primary Care Dia | KGI |
| Oct 16, 2008 | K082402 | OSDX HIP BMD SYSTEM Imaging Therapeutics, Inc. | KGI |
| Sep 26, 2008 | K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION General Electric Co. | KGI |
| Sep 2, 2008 | K080711 | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION Hologic, Inc. | KGI |
| Mar 28, 2008 | K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS Hologic, Inc. | KGI |
| Sep 14, 2007 | K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT Ge Medical Systems Ultrasound and Primary Care Dia | KGI |
| Jun 27, 2007 | K071570 | GE LUNAR BODY COMPOSITION SOFTWARE Ge Medical Systems Lunar | KGI |
| Jul 28, 2006 | K061561 | HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS Hologic, Inc. | KGI |
| Apr 24, 2006 | K060111 | IVA (MXA II SOFTWARE OPTION) Hologic, Inc. | KGI |
| Oct 20, 2005 | K052581 | LUNAR IDXA Ge Medical Systems Ultrasound and Primary Care Dia | KGI |
| Oct 29, 2004 | K042480 | INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS Hologic, Inc. | KGI |
| Aug 11, 2004 | K041266 | PEDIATRIC REFERENCE DATABASE Hologic, Inc. | KGI |
| May 5, 2004 | K033550 | DXL CALSCAN Demetech AB, SE | KGI |
| Nov 5, 2003 | K033224 | HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER Hologic, Inc. | KGI |
| Jul 30, 2003 | K031991 | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS Image Analysis, Inc. | KGI |
| Jul 25, 2003 | K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER Ge Lunar Corp. | KGI |
| Jun 20, 2003 | K030330 | CTXA HIP EXTENDED REFERENCE DATA Mindways Software, Inc. | KGI |
| Dec 20, 2002 | K023554 | DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE Ge Lunar Corp. | KGI |
| Nov 8, 2002 | K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY Hologic, Inc. | KGI |
| Jun 7, 2002 | K021527 | SECTRA OSTEOPOROSIS PACKAGE Sectra-Imtec AB | KGI |
| May 21, 2002 | K021331 | DEXACARE G4 Osteometer Meditech, Inc. | KGI |
| Dec 4, 2001 | K002113 | CTXA HIP; CTXA; QCT PRO CTXA HIP Mindways Software, Inc. | KGI |
| Aug 3, 2001 | K011917 | ADVANCED HIP ASSESSMENT SOFTWARE Ge Lunar Corp. | KGI |
| Dec 15, 2000 | K003656 | X-POSURE SYSTEM VERSION 2 MAMMO Pronosco A/S | KGI |
| Oct 23, 2000 | K002500 | X-POSURE SYSTEM VERSION 2 RAD Pronosco A/S | KGI |
| Sep 28, 2000 | K002711 | HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER Hologic, Inc. | KGI |
| Jul 10, 2000 | K001812 | PEDIATRIC REFERENCE DATA Lunar Corp. | KGI |
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