510(k) · Cleared
ClearedSingle Energy (SE) Femur Exams
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on May 31, 2013 as substantially equivalent to K060111 (Hologic, Inc., 2006) after a 116-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945668 (1994). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945668 KXO-80GToshiba America Medical Systems, In.C · 1994
- 1 generation backK060111 Iva (Mxa II Software Option)Hologic, Inc. · 2006
- This deviceK130277 Single Energy (SE) Femur ExamsHologic, Inc. · 2013
- 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 |
|---|---|---|---|---|---|
| −2 | K945668 | KXO-80G | Toshiba America Medical Systems, In.C | 1994 | — |
| −1 | K060111 | Iva (Mxa II Software Option) | Hologic, Inc. | 2006 | — |
| 0 (this device) | K130277 | Single Energy (SE) Femur Exams | Hologic, Inc. | 2013 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
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 |
|---|---|---|---|
| * | K060111 | Iva (Mxa II Software Option)Summary page 2…90 KGI 3.5 Prescription Use The use of the Single Energy (SE) Femur Exam is restricted to prescription use only. 3.6 Predicate Devices * 510(k) No: K060111 Trade Name: IVA (MXA-ll) software option for the X-Ray bone dlensitometer SE Date: 4/4/2006 Manufacturer:… | 2006 |
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 19 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 4 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.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130277: Single Energy (SE) Femur Exams.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130277
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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