510(k) · Cleared
ClearedEncore 14 Software Release for the GE Lunar Dxa Bone Densitometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Lunar · KGI Densitometer, Bone
Cleared on Apr 27, 2012 as substantially equivalent to K071570 (Ge Medical Systems Lunar, 2007) after a 172-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 172 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935454 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
- 2 generations backK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
- 1 generation backK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
- This deviceK113286 Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012
- 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 · 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
- Descendant · 2 generations on · 0 of its ownK180782 AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018
Most influential descendants
Showing 5 of 5 · 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
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 3 generations on0descendants
- K2510223D-Shaper3D-Shaper Medical S.L · 2025 · 3 generations on0descendants
- K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935454 | DPX Tissue Quantification Output | Lunar Corp. | 1995 | — |
| −2 | K973459 | Norland Body Composition Option for Norland Dexa Bone Densitometers | Norland Corp. | 1998 | — |
| −1 | K071570 | GE Lunar Body Composition Software | Ge Medical Systems Lunar | 2007 | — |
| 0 (this device) | K113286 | Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers | Ge Medical Systems Lunar | 2012 | — |
| +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 |
| +3 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +3 | K251022 | 3D-Shaper | 3D-Shaper Medical S.L | 2025 | — |
| +2 | K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (1)
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 1…ct Code: KGI Predicate Device(s): Body Composition Software Option for GE Lunar DEXA Bone Densitometers (K07 1570) Device Description: enCORE is the software is used by the series of GE Lunar DXA… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | 2016 | 4 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161682 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2016) has gone furthest, with 4 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. 2012, 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 enCORE software used on the GE Lunar bone densitometer total body scan estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be…
Read the full statement (140 words)
The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends.
The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends.
The Mirrorlmage fuinction in the enCORE software used on the GE Lunar DXA bone densitometers can be used to estimate the total body composition and bone mineral density (BMLD) when regions of the body are outside of the scan window by using scanned data from the corresponding region(s) on the opposite half of the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113286: Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113286
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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