FDA Product Code
FDA Product Code KGI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1170
510(k) Clearances — 148 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254072 | BoneVue | Curvebeam AI / Curvebeam, LLC | 2026-09-11 | Traditional | PDF ↗ |
| K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-04-20 | Traditional | PDF ↗ |
| K251022 | 3D-SHAPER | 3D-Shaper Medical S.L | 2025-09-05 | Traditional | PDF ↗ |
| K242295 | BunkerHill BMD | BunkerHill Health | 2025-04-08 | Traditional | PDF ↗ |
| K243218 | TBS iNsight (V4) | Medimaps Group SA | 2025-01-17 | Traditional | PDF ↗ |
| K220402 | VirtuOst | O.N. Diagnostics | 2023-05-19 | Traditional | PDF ↗ |
| K220822 | 3D-SHAPER | 3D-Shaper Medical S.L | 2022-12-09 | Traditional | PDF ↗ |
| K213760 | ABMD Software | HeartLung Corporation | 2022-07-29 | Traditional | PDF ↗ |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019-09-19 | Traditional | PDF ↗ |
| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-04-20 | Traditional | PDF ↗ |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-12-02 | Traditional | PDF ↗ |
| K152299 | TBS iNsight | Medimaps Group SA | 2016-04-29 | Traditional | PDF ↗ |
| K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | Mindways Software, Inc. | 2014-08-29 | Traditional | PDF ↗ |
| K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014-05-15 | Traditional | PDF ↗ |
| K130277 | SINGLE ENERGY (SE) FEMUR EXAMS | Hologic, Inc. | 2013-05-31 | Traditional | PDF ↗ |
| K121716 | TBS INSIGHT | Medimaps Group SA | 2012-10-05 | Traditional | PDF ↗ |
| K113725 | VIRTUOST | O.N. Diagnostics | 2012-09-13 | Traditional | PDF ↗ |
| K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012-04-27 | Traditional | PDF ↗ |
| K113286 | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Lunar | 2012-04-27 | Traditional | PDF ↗ |
| K113356 | HOLOGIC VISCERAL FAT SOFTWARE | Hologic, Inc. | 2012-03-06 | Traditional | PDF ↗ |
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | 2011-05-06 | Traditional | PDF ↗ |
| K103265 | NHANES WHOLE BODY DXA REFERENCE DATABASE | Hologic, Inc. | 2011-03-16 | Traditional | PDF ↗ |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS | Cooper Surgical | 2009-06-29 | Traditional | PDF ↗ |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-11-21 | Traditional | PDF ↗ |
| K082402 | OSDX HIP BMD SYSTEM | Imaging Therapeutics, Inc. | 2008-10-16 | Traditional | PDF ↗ |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | General Electric Co. | 2008-09-26 | Traditional | PDF ↗ |
| K080711 | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION | Hologic, Inc. | 2008-09-02 | Traditional | PDF ↗ |
| K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | 2008-03-28 | Traditional | PDF ↗ |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | Ge Medical Systems Ultrasound and Primary Care Dia | 2007-09-14 | Special | PDF ↗ |
| K071570 | GE LUNAR BODY COMPOSITION SOFTWARE | Ge Medical Systems Lunar | 2007-06-27 | Traditional | PDF ↗ |
| K061561 | HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | 2006-07-28 | Traditional | PDF ↗ |
| K060111 | IVA (MXA II SOFTWARE OPTION) | Hologic, Inc. | 2006-04-24 | Traditional | PDF ↗ |
| K052581 | LUNAR IDXA | Ge Medical Systems Ultrasound and Primary Care Dia | 2005-10-20 | Special | PDF ↗ |
| K042480 | INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS | Hologic, Inc. | 2004-10-29 | Traditional | PDF ↗ |
| K041266 | PEDIATRIC REFERENCE DATABASE | Hologic, Inc. | 2004-08-11 | Traditional | PDF ↗ |
| K033550 | DXL CALSCAN | Demetech AB | 2004-05-05 | Traditional | PDF ↗ |
| K033224 | HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER | Hologic, Inc. | 2003-11-05 | Special | PDF ↗ |
| K031991 | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS | Image Analysis, Inc. | 2003-07-30 | Special | PDF ↗ |
| K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER | Ge Lunar Corp. | 2003-07-25 | Traditional | PDF ↗ |
| K030330 | CTXA HIP EXTENDED REFERENCE DATA | Mindways Software, Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K023554 | DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE | Ge Lunar Corp. | 2002-12-20 | Traditional | PDF ↗ |
| K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY | Hologic, Inc. | 2002-11-08 | Special | PDF ↗ |
| K021527 | SECTRA OSTEOPOROSIS PACKAGE | Sectra-Imtec AB | 2002-06-07 | Special | PDF ↗ |
| K021331 | DEXACARE G4 | Osteometer Meditech, Inc. | 2002-05-21 | Special | PDF ↗ |
| K002113 | CTXA HIP; CTXA; QCT PRO CTXA HIP | Mindways Software, Inc. | 2001-12-04 | Traditional | PDF ↗ |
| K011917 | ADVANCED HIP ASSESSMENT SOFTWARE | Ge Lunar Corp. | 2001-08-03 | Traditional | PDF ↗ |
| K003656 | X-POSURE SYSTEM VERSION 2 MAMMO | Pronosco A/S | 2000-12-15 | Special | PDF ↗ |
| K002500 | X-POSURE SYSTEM VERSION 2 RAD | Pronosco A/S | 2000-10-23 | Traditional | PDF ↗ |
| K002711 | HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER | Hologic, Inc. | 2000-09-28 | Traditional | PDF ↗ |
| K001812 | PEDIATRIC REFERENCE DATA | Lunar Corp. | 2000-07-10 | Traditional | PDF ↗ |
| K001756 | LUNAR REPORT GENERATOR II | Lunar Corp. | 2000-07-06 | Traditional | PDF ↗ |
| K993176 | MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY | Norland Medical Systems, Inc. | 2000-06-20 | Traditional | PDF ↗ |
| K001429 | MODIFICATION TO ACCUDEXA BONE DENSITOMETER | Schick Technologies, Inc. | 2000-05-26 | Special | PDF ↗ |
| K993337 | APOLLO MULTI-RACIAL REFERENCE POPULATION | Norland Medical Systems, Inc. | 2000-05-16 | Traditional | PDF ↗ |
| K000162 | METRISCAN BONE DENSITY SYSTEM | Alara, Inc. | 2000-05-12 | Traditional | PDF ↗ |
| K000826 | PRODIGY LATERAL VIEW SOFTWARE | Lunar Corp. | 2000-04-14 | Traditional | PDF ↗ |
| K992125 | XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 | Norland Medical Systems, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K992775 | OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W | Hologic, Inc. | 1999-10-01 | Traditional | PDF ↗ |
| K992246 | QCT BONE MINERAL ANALYSIS SOFTWARE | Image Analysis, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K992677 | EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W | Hologic, Inc. | 1999-09-03 | Special | PDF ↗ |
| K984285 | OSTEOGRAM BONE DENSITOMETER | Compumed, Inc. | 1999-05-19 | Traditional | PDF ↗ |
| K984178 | PRONOSCO X-POSURE SYSTEM | Torsana Osteoporosis Diagnostics A/S | 1999-02-18 | Traditional | PDF ↗ |
| K983724 | ORCA-DX BONE DENSITOMETER | Lunar Corp. | 1998-12-08 | Traditional | PDF ↗ |
| K983564 | PRODIGY TOTAL BODY SOFTWARE | Lunar Corp. | 1998-12-08 | Traditional | PDF ↗ |
| K983271 | FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS | Lunar Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K983262 | FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS | Lunar Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K983269 | FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER | Lunar Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K983028 | FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W | Hologic, Inc. | 1998-11-13 | Traditional | PDF ↗ |
| K983273 | XCT 2000 L PQCT BONE DENSITOMETER | Medical Systems, Inc. | 1998-10-29 | Traditional | PDF ↗ |
| K982267 | DPX-RX BONE DENSITOMETER | Lunar Corp. | 1998-08-18 | Traditional | PDF ↗ |
| K980569 | FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS | Norland Corp. | 1998-06-12 | Traditional | PDF ↗ |
| K980289 | FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER | Norland Corp. | 1998-06-12 | Traditional | PDF ↗ |
| K981124 | ACCUDEXA BONE DENSITOMETER | Schick Technologies, Inc. | 1998-06-04 | Traditional | PDF ↗ |
| K980125 | REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER | Norland Corp. | 1998-05-20 | Traditional | PDF ↗ |
| K973459 | NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS | Norland Corp. | 1998-02-13 | Traditional | PDF ↗ |
| K974437 | EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE | Lunar Corp. | 1998-02-13 | Traditional | PDF ↗ |
| K973104 | NORLAND MODEL PDEXA BONE DENSITOMETER | Norland Corp. | 1998-01-29 | Traditional | PDF ↗ |
| K971735 | ACCUDEXA BONE DENSITOMETER | Schick Technologies, Inc. | 1997-12-02 | Traditional | PDF ↗ |
| K972517 | EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE | Lunar Corp. | 1997-11-18 | Traditional | PDF ↗ |
| K972882 | APOLLO | Norland Corp. | 1997-10-31 | Traditional | PDF ↗ |
| K964562 | DTX-200 BONE DENSITOMETER | Osteometer Meditech A/S | 1997-08-22 | Traditional | PDF ↗ |
| K972053 | PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM | Lunar Corp. | 1997-08-08 | Traditional | PDF ↗ |
| K963789 | DTX-100 BONE DENSITOMETER | Osteometer Meditech A/S | 1997-07-14 | Traditional | PDF ↗ |
| K961787 | BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K970224 | PIXI BONE DENSITOMETER | Lunar Corp. | 1997-04-16 | Traditional | PDF ↗ |
| K964307 | EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS | Lunar Corp. | 1997-04-16 | Traditional | PDF ↗ |
| K963363 | HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS | Hologic, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K964263 | EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE | Lunar Corp. | 1996-11-07 | Traditional | PDF ↗ |
| K961007 | EXPERT SPINE MORPHOTIETRY REFERENCE | Lunar Corp. | 1996-07-25 | Traditional | PDF ↗ |
| K961011 | DTX-200 BONE DENSITOMETER | Shotwell & Carr, Inc. | 1996-07-05 | Traditional | PDF ↗ |
| K961944 | LUNAR REPORT GENERATOR | Lunar Corp. | 1996-07-03 | Traditional | PDF ↗ |
| K953032 | LUNAR DPX DENSITOMETER | Lunar Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K941362 | BONE MINERAL DENSITOMETER | Hologic, Inc. | 1995-08-30 | Traditional | PDF ↗ |
| K952060 | QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 | Image Analysis, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K950611 | EXPERT MORPHOMERTY SOFTWARD | Lunar Corp. | 1995-05-24 | Traditional | PDF ↗ |
| K941127 | QCT-BONE MINERAL ANALYSIS SOFTWARE | Image Analysis, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K941126 | QCT-BONE MINERAL ANALYSIS PHANTOM | Image Analysis, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K945526 | LUNAR EXPERT | Lunar Corp. | 1995-04-25 | Traditional | PDF ↗ |
| K931996 | MODEL PDEXA BONE DENSITOMETER | Norland Corp. | 1995-02-01 | Traditional | PDF ↗ |
| K943505 | HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER | Hologic, Inc. | 1995-01-20 | Traditional | PDF ↗ |
Product code KGI · Class II · Radiology. Data: openFDA.