510(k) · Cleared
ClearedABMD Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HeartLung Corporation · KGI Densitometer, Bone
Cleared on Jul 29, 2022 as substantially equivalent to K894854 (Image Enhancements, 1989) after a 240-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jul 29, 2022
- Review
- 240 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894854 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK894854 QCT Bone Mineral Density Analysis SoftwareImage Enhancements · 1989
- This deviceK213760 ABMD SoftwareHeartLung Corporation · 2022
- Descendant · cites it directly · 0 of its ownK252029 AI-CVDHeartLung Corporation · 2025
- Descendant · cites it directly · 0 of its ownK242295 BunkerHill BMDBunkerHill Health · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894854 | QCT Bone Mineral Density Analysis Software | Image Enhancements | 1989 | — |
| 0 (this device) | K213760 | ABMD Software | HeartLung Corporation | 2022 | — |
| +1 | K252029 | AI-CVD | HeartLung Corporation | 2025 | — |
| +1 | K242295 | BunkerHill BMD | BunkerHill Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K894854 | QCT Bone Mineral Density Analysis SoftwareSummary page 4…92.1170 Product Code: KGI 3. Predicate Device Manufacturer: Mindways Trade Name: QCT Bone Mineral Density Analysis Software Predicate 510(k): K894854 Classification: Class II, 21 CFR 892.1170 Product Code: KGI 4. Reference Device Manufacturer: Mindways… | 1989 |
| † | K140342 | QCT Pro Asynchronous Calibration Module, Cliniqct | 2014 |
What descends from it? (2)
2 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?
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Automated Bone Mineral Density Software Module (ABMD) is a post-processing Al-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In…
Read the full statement (123 words)
The Automated Bone Mineral Density Software Module (ABMD) is a post-processing Al-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic Al-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213760: ABMD Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213760
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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