Product code KGI
- Device name
- Densitometer, Bone
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1170
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-04-20 |
| K251022 | 3D-SHAPER | 3D-Shaper Medical S.L | 2025-09-05 |
| K242295 | BunkerHill BMD | BunkerHill Health | 2025-04-08 |
| K243218 | TBS iNsight (V4) | Medimaps Group SA | 2025-01-17 |
| K220402 | VirtuOst | O.N. Diagnostics | 2023-05-19 |
| K220822 | 3D-SHAPER | 3D-Shaper Medical S.L | 2022-12-09 |
| K213760 | ABMD Software | HeartLung Corporation | 2022-07-29 |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019-09-19 |
| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-04-20 |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-12-02 |
| K152299 | TBS iNsight | Medimaps Group SA | 2016-04-29 |
| K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | Mindways Software, Inc. | 2014-08-29 |
| K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014-05-15 |
| K130277 | SINGLE ENERGY (SE) FEMUR EXAMS | Hologic, Inc. | 2013-05-31 |
| K113725 | VIRTUOST | O.N. Diagnostics | 2012-09-13 |
| K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012-04-27 |
| K113286 | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Lunar | 2012-04-27 |
| K113356 | HOLOGIC VISCERAL FAT SOFTWARE | Hologic, Inc. | 2012-03-06 |
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | 2011-05-06 |
| K103265 | NHANES WHOLE BODY DXA REFERENCE DATABASE | Hologic, Inc. | 2011-03-16 |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS | Cooper Surgical | 2009-06-29 |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-11-21 |
| K082402 | OSDX HIP BMD SYSTEM | Imaging Therapeutics, Inc. | 2008-10-16 |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | General Electric Co. | 2008-09-26 |
| K080711 | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION | Hologic, Inc. | 2008-09-02 |
| K072847 | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | 2008-03-28 |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | Ge Medical Systems Ultrasound and Primary Care Dia | 2007-09-14 |
| K071570 | GE LUNAR BODY COMPOSITION SOFTWARE | Ge Medical Systems Lunar | 2007-06-27 |
| K061561 | HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS | Hologic, Inc. | 2006-07-28 |
| K060111 | IVA (MXA II SOFTWARE OPTION) | Hologic, Inc. | 2006-04-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08437021740066 | 3D-SHAPER | 3D-SHAPER MEDICAL S.L. | 2026-05-12 |
| B214OSTBSIV400 | TBS iNsight | medimaps group SA | 2025-02-13 |
| 08437021740028 | 3D-SHAPER | 3D-SHAPER MEDICAL S.L. | 2023-10-04 |
| B052PHCTM40 | Model 4 CT Calibration Phantom | MINDWAYS SOFTWARE, INC. | 2023-05-04 |
| B214OSPTMV30 | Phantom | medimaps group SA | 2022-12-08 |
| B214OSPTM3 | Phantom | medimaps group SA | 2022-12-08 |
| B214OSTBSI3120 | TBS iNsight | medimaps group SA | 2022-01-13 |
| 00866955000478 | IlluminatusDXA Software | Norland at Swissray | 2020-07-27 |
| B214OSTBSI3110 | TBS iNsight | medimaps group SA | 2020-06-25 |
| B214OSTBSI3100 | TBS iNsight | medimaps group SA | 2020-02-28 |
| 00840682138352 | Prodigy | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2018-07-03 |
| 00840682138345 | Prodigy | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2018-07-03 |
| 15420045507494 | APEX Practice Managment Tool | Hologic, Inc. | 2018-04-04 |
| 15420045506916 | Discovery W | Hologic, Inc. | 2017-11-15 |
| 15420045506909 | Discovey C | Hologic, Inc. | 2017-11-15 |
| 15420045506893 | Discovery SL | Hologic, Inc. | 2017-11-15 |
| 15420045506879 | Discovery A | Hologic, Inc. | 2017-09-22 |
| B052DICTXAHIP0 | CTXA Hip Bone Mineral Densitometer | MINDWAYS SOFTWARE, INC. | 2017-03-31 |
| B052DIASYNC0 | QCT Pro Asynchronous Calibration Module, CliniQCT | MINDWAYS SOFTWARE, INC. | 2017-03-31 |
| B214OSTBSI30 | TBS iNsight | medimaps group SA | 2017-02-07 |
| 15420045505865 | Horizon Wi | Hologic, Inc. | 2016-12-09 |
| 15420045505872 | Discovery Ci | Hologic, Inc. | 2016-08-23 |
| 15420045505889 | Discovery Wi | Hologic, Inc. | 2016-08-23 |
| 15420045505834 | Horizon W | Hologic, Inc. | 2016-08-23 |
| 15420045505827 | Horizon Ci | Hologic, Inc. | 2016-08-23 |
| 15420045505698 | Horizon C | Hologic, Inc. | 2016-08-23 |
| 15420045505384 | Horizon A | Hologic, Inc. | 2016-08-23 |
| 00840682117098 | Prodigy | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2016-06-27 |
| 00840682117029 | Lunar iDXA | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2016-06-27 |
| 00840682117142 | Prodigy | GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC | 2016-06-27 |