GE Lunar Frax 10-YEAR Fracture Risk Software Option
FDA 510(k) K082317 · General Electric Co.
510(k) numberK082317
Submission
- Device name
- GE Lunar Frax 10-YEAR Fracture Risk Software Option
- Applicant
- General Electric Co.
Madison, WI, US - Received
- August 13, 2008
- Decision date
- September 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KGI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18KGI · Traditional | GE Medical Systems Ultrasound & Primary Care… | 09/19/2019SE |
| K180782 | AriaKGI · Traditional | GE Medical Systems Ultrasound & Primary Care… | 04/20/2018SE |
More from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K110798 | Senographe DS, Senographe EssentialMUE · Traditional | 12/22/2011SE |
| K103485 | Senograph DS, Senograph EssenstialMUE · Traditional | 10/06/2011SE |
| K103489 | GE Veo Reconstruction OptionJAK · Traditional | 09/09/2011SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
| K063006 | GE Logiq WorksLLZ · Special | 11/02/2006SE |
Questions and answers
When was GE Lunar Frax 10-YEAR Fracture Risk Software Option cleared by the FDA?
GE Lunar Frax 10-YEAR Fracture Risk Software Option (K082317) received a 510(k) decision of Substantially Equivalent on September 26, 2008, 44 days after the submission was received.
What is the product code of K082317?
The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.