ABMD Software

K213760

HeartLung Corporation · cleared 2022-07-29 · product code KGI · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones.”
AlgorithmAI 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 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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=993 cases

endpoints: correlation with manual QCT BMD; agreement with manual QCT BMD

Retrospective clinical

n=172 cases

endpoints: correlation with DXA BMD; agreement with DXA BMD; correlation with manual QCT BMD; agreement with manual QCT BMD

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

1
recalls in product code, 24mo
6
MAUDE reports in code, 12mo
+200%
vs code's own 3-yr baseline
1
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213760