KGI · Densitometer, Bone
Radiology · 21 CFR 892.1170 · Class 2
Overview
| Product Code | KGI |
|---|---|
| Device Name | Densitometer, Bone |
| Regulation | 21 CFR 892.1170 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 146)
Showing 20 most recent of 146 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251022 | 3D-SHAPER | 3D-Shaper Medical S.L | Sep 5, 2025 | SESE |
| K242295 | BunkerHill BMD | BunkerHill Health | Apr 8, 2025 | SESE |
| K243218 | TBS iNsight (V4) | Medimaps Group SA | Jan 17, 2025 | SESE |
| K220402 | VirtuOst | O.N. Diagnostics | May 19, 2023 | SESE |
| K220822 | 3D-SHAPER | 3D-Shaper Medical S.L | Dec 9, 2022 | SESE |
| K213760 | ABMD Software | HeartLung Corporation | Jul 29, 2022 | SESE |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Sep 19, 2019 | SESE |
| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Apr 20, 2018 | SESE |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Dec 2, 2016 | SESE |
| K152299 | TBS iNsight | Medimaps Group SA | Apr 29, 2016 | SESE |
| K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | Mindways Software, Inc. | Aug 29, 2014 | SESE |
| K133664 | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Ultrasound & Primary Care Diagn | May 15, 2014 | SESE |
| K130277 | SINGLE ENERGY (SE) FEMUR EXAMS | Hologic, Inc. | May 31, 2013 | SESE |
| K121716 | TBS INSIGHT | Medimaps Group SA | Oct 5, 2012 | SESE |
| K113725 | VIRTUOST | O.N. Diagnostics | Sep 13, 2012 | SESE |
| K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | Apr 27, 2012 | SESE |
| K113286 | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS | Ge Medical Systems Lunar | Apr 27, 2012 | SESE |
| K113356 | HOLOGIC VISCERAL FAT SOFTWARE | Hologic, Inc. | Mar 6, 2012 | SESE |
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | Ge Medical Systems Ultrasound and Primary Care Dia | May 6, 2011 | SESE |
| K103265 | NHANES WHOLE BODY DXA REFERENCE DATABASE | Hologic, Inc. | Mar 16, 2011 | SESE |
Top Applicants
- Hologic, Inc. — 29 clearances
- Lunar Corp. — 20 clearances
- Norland Corp. — 15 clearances
- Image Analysis, Inc. — 7 clearances
- Lunar — 6 clearances
