ABMD Software
K213760HeartLung Corporation · cleared 2022-07-29 · product code KGI · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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.”
source quote (p.5)
“The ABMD Software uses an AI trained model to segment out vertebral bones in the field of view and subsequently measures the average of the Hounsfield unit, HU, in a cylinder volume within the trabecular tissue of each vertebral bone without including the cortical bone.”
source quote (p.5)
“The end user cannot change or edit the segmentation or results of the device.”
Validation studies (2)
Retrospective clinical
n=993 cases
endpoints: Correlation with manual QCT BMD; Correlation with manual QCT T-score; Correlation with manual QCT Z-score; Agreement with manual QCT BMD; Agreement with manual QCT T-score; Agreement with manual QCT Z-score
Retrospective clinical
n=172 cases
endpoints: Correlation with DXA T-score; Correlation with DXA Z-score; Correlation with QCT BMD; Correlation with QCT T-score; Correlation with QCT Z-score; Agreement with DXA T-score; Agreement with DXA Z-score; Agreement with QCT BMD; Agreement with QCT T-score; Agreement with QCT Z-score
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code KGI (Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland, initiated 2025-02-03): "Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96233
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).