510(k) · Cleared
ClearedExpert Morphomerty Softward
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · KGI Densitometer, Bone
Cleared on May 24, 1995 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- May 24, 1995
- Review
- 103 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 3 citing it directly.
- This deviceK950611 Expert Morphomerty SoftwardLunar Corp. · 1995
- Descendant · cites it directly · 17 of its ownK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
- Descendant · cites it directly · 16 of its ownK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
- Descendant · 2 generations on · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
- Descendant · 3 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K961007Expert Spine Morphotietry ReferenceLunar Corp. · 1996 · cites it directly17descendants
- K011917Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001 · cites it directly16descendants
- K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · 2 generations on13descendants
- K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 2 generations on7descendants
- K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950611 | Expert Morphomerty Softward | Lunar Corp. | 1995 | — |
| +1 | K961007 | Expert Spine Morphotietry Reference | Lunar Corp. | 1996 | — |
| +1 | 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 | — |
| +2 | K072664 | GE Lunar Femur Strength Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | — |
| +3 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 223 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?
- Of its descendants, K961007 (Lunar Corp., 1996) has gone furthest, with 17 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.
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 | — |
https://510kreport.com/device/K950611 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950611: Expert Morphomerty Softward.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950611
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026