GEHC DXA Bone Densitometers with enCORE version 18
FDA 510(k) K191112 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
510(k) numberK191112
Submission
- Device name
- GEHC DXA Bone Densitometers with enCORE version 18
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Madison, WI, US - Received
- April 26, 2019
- Decision date
- September 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K254072 | BoneVueKGI · Traditional | Curvebeam AI / Curvebeam, LLC | 09/11/2026SE |
| K252718 | Lunar AstraKGI · Traditional | GE Medical Systems Ultrasound & Primary Care… | 04/20/2026SE |
| K251022 | 3D-SHAPERKGI · Traditional | 3D-Shaper Medical S.L | 09/05/2025SE |
| K242295 | BunkerHill BMDKGI · Traditional | BunkerHill Health | 04/08/2025SE |
| K243218 | TBS iNsight (V4)KGI · Traditional | Medimaps Group SA | 01/17/2025SE |
| K220402 | VirtuOstKGI · Traditional | O.N. Diagnostics | 05/19/2023SE |
| K220822 | 3D-SHAPERKGI · Traditional | 3D-Shaper Medical S.L | 12/09/2022SE |
| K213760 | ABMD SoftwareKGI · Traditional | HeartLung Corporation | 07/29/2022SE |
| K180782 | AriaKGI · Traditional | GE Medical Systems Ultrasound & Primary Care… | 04/20/2018SE |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17KGI · Traditional | GE Medical Systems Ultrasound & Primary Care… | 12/02/2016SE |
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| K200158 | Logiq E10IYN · Traditional | 04/17/2020SE |
| K181934 | Vivid T8, Vivid T9IYN · Traditional | 11/06/2018SE |
| K180782 | AriaKGI · Traditional | 04/20/2018SE |
| K170714 | VenueIYN · Traditional | 06/21/2017SE |
| K170878 | Vivid S60N, Vivid S70NIYN · Traditional | 06/14/2017SE |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17KGI · Traditional | 12/02/2016SE |
Questions and answers
When was GEHC DXA Bone Densitometers with enCORE version 18 cleared by the FDA?
GEHC DXA Bone Densitometers with enCORE version 18 (K191112) received a 510(k) decision of Substantially Equivalent on September 19, 2019, 146 days after the submission was received.
What is the product code of K191112?
The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.