510(k) · Cleared
ClearedGE Lunar Frax 10-Year Fracture Risk Software Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · KGI Densitometer, Bone
Cleared on Sep 26, 2008 as substantially equivalent to K983271 (Lunar Corp., 1998) and 1 other predicate after a 44-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973104 (1998). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- 1 generation backK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
- This deviceK082317 GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008
- Descendant · cites it directly · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
- Descendant · 3 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152299TBS iNsightMedimaps Group SA · 2016 · cites it directly4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 2 generations on2descendants
- K202514EchoS FamilyEcholight S.P.A · 2021 · cites it directly1descendant
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 3 generations on0descendants
- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −1 | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000… | Hologic, Inc. | 1998 | — |
| 0 (this device) | K082317 | GE Lunar Frax 10-Year Fracture Risk Software Option | General Electric Co. | 2008 | — |
| +1 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
| +2 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +1 | K202514 | EchoS Family | Echolight S.P.A | 2021 | — |
| +3 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +3 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983271 | Fracture Risk Assessment Option for DPX Series Bone DensitometersSummary page 1…X TM 10-year fracture risk software option Bone Densitometer, 21 CFR 892.1170, 90-KGI 3. Marketed Device: Fracture Risk for DPX bone densitometers K983271 Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers K983028 4. Device Description: The FRAXT a… | 1998 |
| * | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Summary page 1….1170, 90-KGI 3. Marketed Device: Fracture Risk for DPX bone densitometers K983271 Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers K983028 4. Device Description: The FRAXT a 10-Year Fracture Risk software option for GE Lunar Bone densitometers… | 1998 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152299 (Medimaps Group SA, 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The FRAX TM 10-Year Fracture Risk software option is an accessory to currently marketed GE Lunar bone densitometer devices, which are intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians. This software option is intended to provide an assessment of 10-year fracture risk. The option provides an estimate of 10-year probability of hip fracture and 10-year…
Read the full statement (207 words)
The FRAX TM 10-Year Fracture Risk software option is an accessory to currently marketed GE Lunar bone densitometer devices, which are intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians.
This software option is intended to provide an assessment of 10-year fracture risk. The option provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAXTM Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082317: GE Lunar Frax 10-Year Fracture Risk Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082317
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026