510(k) K113286
- Device
- ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
- Applicant
- GE MEDICAL SYSTEMS LUNAR
- 510(k) number
- K113286
- Product code
- KGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-27
- Date received
- 2011-11-07
- Regulation
- 892.1170
- Classification name
- Densitometer, Bone
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TRISHIA DWYER
- Address
- 3030 Ohmeda Dr. Madison WI US 53718 53718
FDA Registration Numbers#
- 3008921184
- 3031503890
- 3008496839
- 3010208539
- 9616391
- 3026043045
- 3015276088
- 3003600763
- 3027245002
- 3008632256
- 3039211310
- 3036666444
- 2939827
- 3005496266
- 9616047
- 3010687441
- 3019373577
- 3004977335
- 2183066
- 3010703925
- 3023003446
Source Documents#
Other 510(k) Records For Product Code KGI #
| 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 |
| K121716 | TBS INSIGHT | Medimaps Group SA | 2012-10-05 |
Legacy Summary#
summary
FDA Review#
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