510(k) · Cleared
Recalled · Class II · 2019GE Lunar DXA Bone Densitometers with enCORE version 17
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · KGI Densitometer, Bone
Cleared on Dec 2, 2016 as substantially equivalent to K071570 (Ge Medical Systems Lunar, 2007) and 4 other predicates after a 168-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 2, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K890121 (1990). 25 ancestors in all, the oldest K883280 (1988). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 4 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 3 generations backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- 2 generations backK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- 1 generation backK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- This deviceK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016
- Descendant · cites it directly · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK251022 3D-Shaper3D-Shaper Medical S.L · 2025
- Descendant · cites it directly · 0 of its ownK180782 AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · cites it directly2descendants
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 2 generations on0descendants
- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 2 generations on0descendants
- K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −4 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −3 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| −2 | K061561 | Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone… | Hologic, Inc. | 2006 | — |
| −1 | K072664 | GE Lunar Femur Strength Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | — |
| 0 (this device) | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | — |
| +1 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +2 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +2 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
| +1 | K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (5)
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 |
|---|---|---|---|
| * | K071570 | GE Lunar Body Composition SoftwareSummary page 6…e Densitometers with enCORE version 17 Predicate Devices: 1. Lunar DXA Bone Densitometers with enCORE software: • Total Body Composition (k071570 – Product Code: KGI) • RSMI - Relative Skeletal Muscle Index (k113286– Product… | 2007 |
| * | K113286 | Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersSummary page 6…enCORE software: • Total Body Composition (k071570 – Product Code: KGI) • RSMI - Relative Skeletal Muscle Index (k113286– Product Code: KGI) • AHA - Advanced Hip Assessment (k072664 – Product… | 2012 |
| * | K072664 | GE Lunar Femur Strength SoftwareSummary page 6…• RSMI - Relative Skeletal Muscle Index (k113286– Product Code: KGI) • AHA - Advanced Hip Assessment (k072664 – Product Code: KGI) • HAL- Hip Axis Length (k011917 – Product Code: KG… | 2008 |
| * | K011917 | Advanced Hip Assessment SoftwareSummary page 6…• AHA - Advanced Hip Assessment (k072664 – Product Code: KGI) • HAL- Hip Axis Length (k011917 – Product Code: KGI) 2. Hologic Bone Densitometers • Single Energy (SE) Femur… | 2001 |
| * | K130277 | Single Energy (SE) Femur ExamsSummary page 6…HAL- Hip Axis Length (k011917 – Product Code: KGI) 2. Hologic Bone Densitometers • Single Energy (SE) Femur Exams (k130277 – Product Code: KGI). Device Description: GE Lunar DXA Bone Densitometers with enCORE version 1… | 2013 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2019 | Class II | Z-1711-2020 | Radiation Control for Health and Safety Act | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K191112 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K071570.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Optional Atypical Femur Fracture (AFF) software uses Femur images to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. This software provides measurements of the lateral and medial cortex width and quantifies focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. Optional sarcopenia…
Read the full statement (110 words)
Optional Atypical Femur Fracture (AFF) software uses Femur images to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. This software provides measurements of the lateral and medial cortex width and quantifies focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans.
Optional sarcopenia software calculates values based on published definitions and thresholds using measured appendicular lean mass in combination with patient demographics and entered values of muscle strength and physical performance. These values may be useful to health care professionals in their management of sarcopenia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161682: GE Lunar DXA Bone Densitometers with enCORE version 17.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161682
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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