510(k) · Cleared
ClearedGE Lunar Femur Strength Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Ultrasound and Primary Care Dia · KGI Densitometer, Bone
Cleared on Nov 21, 2008 as substantially equivalent to K061561 (Hologic, Inc., 2006) and 1 other predicate after a 428-day review. Its family tree reaches back 4 generations to 1990. 7 later devices descend from it.
- Decided
- Nov 21, 2008
- Review
- 428 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K890121 (1990). 17 ancestors in all, the oldest K883280 (1988). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 3 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 2 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 1 generation backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- This deviceK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- Descendant · cites it directly · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 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 ownK113725 VirtuostO.N. Diagnostics · 2012
- 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- K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · cites it directly4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 2 generations on2descendants
- K113725VirtuostO.N. Diagnostics · 2012 · 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 |
|---|---|---|---|---|---|
| −4 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −3 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −2 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| −1 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| 0 (this device) | K072664 | GE Lunar Femur Strength Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | — |
| +1 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 1 |
| +2 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +1 | K113725 | Virtuost | O.N. Diagnostics | 2012 | — |
| +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 |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersSummary page 1…itometer, 21 CFR 892.1170, 90-KGI 3. Marketed Device: Advanced Hip Assessment Software Option K001 191 7, Hologic Hip Structural Analysis software K061 561 currently in commercial distribution. 4. Device Description: The Femur Strength Software Option for GE Lunar DEXA Bone Densitomet… | 2006 |
| * | K011917 | Advanced Hip Assessment Software Our reading of the summary gave K001917, FDA’s number for Parodi Catheter for Angiography (Parca) (Arteria Medical Science, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GE Lunar Prodigy Advanced hip assessment Software option”. | 2001 |
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 18 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K161682 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K061561.
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 GE Lunar Femur Strength analysis software option is an accessory to currently marketed GE Lunar DEXA 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. The Femur Strength software is intended to measure the hip axis length (HAL) and provides female adult Caucasian and Asian mean reference values of HAL from…
Read the full statement (232 words)
The GE Lunar Femur Strength analysis software option is an accessory to currently marketed GE Lunar DEXA 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. The Femur Strength software is intended to measure the hip axis length (HAL) and provides female adult Caucasian and Asian mean reference values of HAL from previously acquired GE Lunar femur scans.
The software calculates hip geometry values used to evaluate the structural properties of the hip, such as sub-region lengths, angles, ratios, buckling ratio, section modulus (Z), cortical thickness, cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI), a strength/stress ratio incorporating geometric properties of the hip such as CSMI, CSA, bone mineral density (BMD), patient age, height and weight. A ScanCheck feature is included to provide online messages to assist the operator or physician in checking that the scan was correctly taken. Color mapping of the variable density of bone images is also provided.
The values measured or computed provide additional information about the structure of the hip. They should be used in conjunction with the BMD T-score and 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/K072664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072664: GE Lunar Femur Strength Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072664
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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