KGI — Densitometer, Bone Class II
FDA product code KGI covers "Densitometer, Bone", a Class II medical device regulated under 21 CFR 892.1170. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KGI
- Device Class
- Class II
- Regulation Number
- 892.1170
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252718 | ge medical systems ultrasound and primary care diagnostics | Lunar Astra | April 20, 2026 |
| K251022 | 3d-shaper medical s.l | 3D-SHAPER | September 5, 2025 |
| K242295 | bunkerhill health | BunkerHill BMD | April 8, 2025 |
| K243218 | medimaps group | TBS iNsight (V4) | January 17, 2025 |
| K220402 | o.n. diagnostics | VirtuOst | May 19, 2023 |
| K220822 | 3d-shaper medical s.l | 3D-SHAPER | December 9, 2022 |
| K213760 | heartlung corporation | ABMD Software | July 29, 2022 |
| K191112 | ge medical systems ultrasound and primary care diagnostics | GEHC DXA Bone Densitometers with enCORE version 18 | September 19, 2019 |
| K180782 | ge medical systems ultrasound and primary care diagnostics | Aria | April 20, 2018 |
| K161682 | ge medical systems ultrasound and primary care diagnostics | GE Lunar DXA Bone Densitometers with enCORE version 17 | December 2, 2016 |
| K152299 | medimaps group | TBS iNsight | April 29, 2016 |
| K140342 | mindways software | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | August 29, 2014 |
| K133664 | ge medical systems ultrasound and primary care diagn | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | May 15, 2014 |
| K130277 | hologic | SINGLE ENERGY (SE) FEMUR EXAMS | May 31, 2013 |
| K121716 | medimaps group | TBS INSIGHT | October 5, 2012 |
| K113725 | o.n. diagnostics | VIRTUOST | September 13, 2012 |
| K113616 | lone oak medical technologies | ACCUDXA2 | April 27, 2012 |
| K113286 | ge medical systems lunar | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS | April 27, 2012 |
| K113356 | hologic | HOLOGIC VISCERAL FAT SOFTWARE | March 6, 2012 |
| K103730 | ge medical systems ultrasound and primary care dia | GE LUNAR VISCERAL FAT SOFTWARE | May 6, 2011 |