510(k) · Cleared
ClearedQCT Bone Mineral Density Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image Enhancements · KGI Densitometer, Bone
Cleared on Oct 19, 1989 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Oct 19, 1989
- Review
- 80 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK894854 QCT Bone Mineral Density Analysis SoftwareImage Enhancements · 1989
- Descendant · cites it directly · 11 of its ownK002113 Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001
- Descendant · 2 generations on · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · 4 generations on · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK213760 ABMD SoftwareHeartLung Corporation · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K002113Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001 · cites it directly11descendants
- K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · 2 generations on6descendants
- K121716TBS InsightMedimaps Group SA · 2012 · 3 generations on5descendants
- K152299TBS iNsightMedimaps Group SA · 2016 · 4 generations on4descendants
- K213760ABMD SoftwareHeartLung Corporation · 2022 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894854 | QCT Bone Mineral Density Analysis Software | Image Enhancements | 1989 | — |
| +1 | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa Hip | Mindways Software, Inc. | 2001 | — |
| +2 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| +3 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +4 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
| +1 | K213760 | ABMD Software | HeartLung Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (17)
See all 174 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, K002113 (Mindways Software, Inc., 2001) has gone furthest, with 11 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/K894854 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894854: QCT Bone Mineral Density Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894854
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026