FDA-cleared profile
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and liver density, bone mineral density, and muscle/fat composition; it is opportunistic decision support, not diagnostic interpretation or risk prediction.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
The FDA decision material does not establish the complete security posture for the exact product and deployment. Obtain architecture, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
Map the installed product, build, options, population, anatomy, inputs, outputs, and enabled functions to K252029 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The FDA package describes either a cloud-based AWS analysis server or an on-premises hospital server; the installed mode, hosting contract, security boundary, and local qualification remain unverified.
exact submission · checked 2026-09-04FDA-described deployment details do not establish current hosting contracts, security controls, uptime, or local qualification.
DICOM CT input and module outputs to the parent software are described in the FDA package; test local PACS/RIS routing, identifiers, result return, and failure handling.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. AI-CVD is not diagnostic interpretation or risk prediction. Except for the labeled CAC function, modules are not standalone; users must review and accept or reject results, and module-specific acquisition and body-region limits apply.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price or product-specific reimbursement was established in the reviewed public material.
Monitor K252029 by exact software, hardware, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-CVD is not diagnostic interpretation or risk prediction. Except for the labeled CAC function, modules are not standalone; users must review and accept or reject results, and module-specific acquisition and body-region limits apply.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
No single product-level sensitivity value was promoted because the reviewed FDA material is workflow, module, sequence, or population specific.
No single product-level specificity value was promoted because the reviewed FDA material is workflow, module, sequence, or population specific.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) verification and validation evidence described in the exact submission · Chest, abdomen, heart, lungs, liver, aorta, pulmonary artery, bone, muscle, and fat
exact submission · Tested version: AI-CVD · Sponsor or vendor studyK252029
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared product version was established. Obtain a written quote separating license, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.
No separate named-product payment identified in reviewed CMS material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 11 PubMed titles and one trial record. Several titles use AI-CVD as a study label, but none states the tested AI-CVD software release or K252029; the trial is unrelated, so all 12 candidates are quarantined. The current discovery snapshot contains 11 PubMed and 1 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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