510(k) · Cleared
Recalled · Class II · 2019Encore Version 16 Software for 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 Ultrasound & Primary Care Diagn · KGI Densitometer, Bone
Cleared on May 15, 2014 as substantially equivalent to K001812 (Lunar Corp., 2000) and 2 other predicates after a 167-day review. Its family tree reaches back 4 generations to 1998. It has been recalled once.
- Decided
- May 15, 2014
- Review
- 167 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K973104 (1998). 16 ancestors in all, the oldest K883280 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
- 3 generations backK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
- 2 generations backK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002 · Recalled
- 1 generation backK042480 Infant Whole Body Software Option for QDR DensitometersHologic, Inc. · 2004
- This deviceK133664 Encore Version 16 Software for GE Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| −3 | K983028 | Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000… | Hologic, Inc. | 1998 | — |
| −2 | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery | Hologic, Inc. | 2002 | 1 |
| −1 | K042480 | Infant Whole Body Software Option for QDR Densitometers | Hologic, Inc. | 2004 | — |
| 0 (this device) | K133664 | Encore Version 16 Software for GE Lunar Dxa Bone Densitometers | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K001812 | Pediatric Reference DataSummary page 2…16.xxl includes same feature enhancements. The software will now expand upon its previously cleared pediatric indication (K001812) by, providing a 'Complete Pediatric" software that can measure the bone mineral… | 2000 |
| * | K042480 | Infant Whole Body Software Option for QDR DensitometersSummary page 2…Reference Data for Prodigy and DPX Bone Densitometers (KO01S 12) infant Whole Body Software Option for QOR Densitometers (K042480) Expert-XL Orthopedic Hip Acquisition and Analysis Software (K972517) Device Des… | 2004 |
| * | K972517 | Expert-XL Orthopedic Hip Acquisition and Analysis SoftwareSummary page 2…nt Whole Body Software Option for QOR Densitometers (K042480) Expert-XL Orthopedic Hip Acquisition and Analysis Software (K972517) Device Description: enCORE software is used on GE Lunar DXA bone densitometers. Release 16 of the en… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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-1710-2020 | 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 16 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 4 other devices also cite its predicate K001812.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 optional "Complete Pediatric" software option measures bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the…
Read the full statement (109 words)
The optional "Complete Pediatric" software option measures bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the physician. The software does not provide a reference population for comparative purposes for patients younger than 5 years of age.
Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133664: Encore Version 16 Software for 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/K133664
Report an extraction error
Are you the manufacturer?
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