510(k) · Cleared
ClearedHip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Jul 28, 2006 as substantially equivalent to K023398 (Hologic, Inc., 2002) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 1990. 13 later devices descend from it.
- Decided
- Jul 28, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890121 (1990). 16 ancestors in all, the oldest K883280 (1988). 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
- 2 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- 1 generation backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- This deviceK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- Descendant · cites it directly · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · 2 generations on · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · cites it directly7descendants
- K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · cites it directly6descendants
- K121716TBS InsightMedimaps Group SA · 2012 · 2 generations on5descendants
- K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · 2 generations on4descendants
- K152299TBS iNsightMedimaps Group SA · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890121 | Modified DPX Bone Densitometer | Lunar | 1990 | — |
| −2 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| −1 | K011917 | Advanced Hip Assessment Software | Ge Lunar Corp. | 2001 | — |
| 0 (this device) | 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 | — |
| +1 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| +2 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +2 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 1 |
| +3 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K023398 | Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoverySummary page 3…510(k) Premnarket Notification H.3.3 Classification Panel Radiology H.3.4 Product Code 90 KGI H.3.S Predicate Devices * 5 10(k) No.: K023398 Trade Name: Discovery Package for QDR Densitometers SE Date: November 8, 2002 Manufactur… | 2002 |
| * | K011917 | Advanced Hip Assessment SoftwareSummary page 3…Trade Name: Discovery Package for QDR Densitometers SE Date: November 8, 2002 Manufacturer: Hologic, Inc. * 510(k) No.: K011917 Trade Name: Advanced Hip Assessment (AHA) Software for GE Prodigy x- ray bone densitomneter… | 2001 |
What descends from it? (13)
See all 133 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 16 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K072664 (Ge Medical Systems Ultrasound and Primary Care Dia, 2008) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K023398.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray 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/K061561
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