Authorized purpose: Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and estimated calcium burden and decides any further action.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and estimated calcium burden and decides any further action.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and estimated calcium burden and decides any further action.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Heart/Cardiovascular Input: Adult non-gated, non-contrast chest CT images, received in DICOM format from compatible CT systems; the FDA comparison lists slice thickness up to 5 mm.
Who uses it?Intended users: Qualified medical professionals such as cardiologists or radiologists.
What does the software produce?Output: An informational circular ROI localizing detected aortic-valve calcium and an estimated Agatston-equivalent calcium score; the quantification can be viewed in the patient report and the ROI in a diagnostic image viewer.
What is its most important limitation?Key limitation: The cleared population is adults aged 40 years and above with non-gated, non-contrast chest CT. The ROI and score are informational, results are not intended for stand-alone use, and physician review of the original report and CT remains required; performance outside the submitted study conditions was not established here.
Clinical takeaway
Clinical role: Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and estimated calcium burden and decides any further action.
Evidence takeaway
Evidence from the reviewed source record: The FDA-described retrospective stand-alone validation used cases from 33 sites across three US geographic regions. Reported agreement bias was -5.15 AU with lower and upper limits of agreement of -200.96 AU and 190.65 AU; circular-ROI precision was 0.826 and recall was 0.855.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and estimated calcium burden and decides any further action.
Adjunctive, on-demand informational support for physician review; the output is not a stand-alone diagnostic decision and does not replace the original report or CT study.
Adult non-gated, non-contrast chest CT images, received in DICOM format from compatible CT systems; the FDA comparison lists slice thickness up to 5 mm.
An informational circular ROI localizing detected aortic-valve calcium and an estimated Agatston-equivalent calcium score; the quantification can be viewed in the patient report and the ROI in a diagnostic image viewer.
The cleared population is adults aged 40 years and above with non-gated, non-contrast chest CT. The ROI and score are informational, results are not intended for stand-alone use, and physician review of the original report and CT remains required; performance outside the submitted study conditions was not established here.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The SaMD interfaces with compatible commercially available CT systems and receives DICOM CT images; the result can be shown as a separate ROI series in a diagnostic viewer or as an estimated score in the patient report while the original study remains available.
The reviewed exact FDA summary and vendor announcement establish the CT/DICOM workflow but do not establish whether the current exact configuration is cloud, on-premises or hybrid.
Security and privacy
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-08
The reviewed sources do not establish exact-release security controls, retention or assurance documentation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
DICOM and physician-review outputs
The cleared workflow accepts non-gated, non-contrast chest CT in DICOM and makes an informational ROI available in a diagnostic viewer plus an estimated calcium score available in the patient report.
Bunkerhill describes AVC as an AI solution that detects and quantifies aortic valve calcification on non-gated, non-contrast chest CT and offers a health-system demo/contact path.
product family · checked 2026-09-08
Vendor announcement content is current buyer context; exact K243229 installation, hosting, security, price and support terms remain unestablished.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
The FDA-described retrospective stand-alone validation used cases from 33 sites across three US geographic regions. Reported agreement bias was -5.15 AU with lower and upper limits of agreement of -200.96 AU and 190.65 AU; circular-ROI precision was 0.826 and recall was 0.855.
DesignRetrospective stand-alone validation with Bland-Altman agreement as the primary endpoint and circular-ROI precision and recall as secondary endpoints.
PopulationCases curated from 33 sites across three geographic regions in the United States; the reviewed FDA summary does not state the total number of cases.
Scopeexact submission
Tested versionBunkerhill AVC configuration submitted in K243229
Sites33
IndependenceSponsor or vendor study
K243229
This is an FDA submission validation study of localization and agreement against established ground truth, not an independent clinical-outcomes study.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-08
No public price or quote for the exact K243229 configuration was reviewed.
Reimbursement and coding
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-08
No exact-product payer policy, coding instruction, or payment determination was established. A general database search cannot prove coverage or noncoverage; verify payer, site of service, coding, and local payment assumptions.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The exact-submission FDA recall query returned no native recall record for K243229. This limited result does not establish absence of recall or other safety information and does not cover later versions, family records, or adverse-event sources.
Public source
Exact FDA submission
Checked 2026-09-07
The local exact-ID recall packet contained zero records; this is a limited query result, not a safety clearance.
Verify deployment and data flow: The reviewed exact FDA summary and vendor announcement establish the CT/DICOM workflow but do not establish whether the current exact configuration is cloud, on-premises or hybrid.
Verify security and privacy controls: The reviewed sources do not establish exact-release security controls, retention or assurance documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public price or quote for the exact K243229 configuration was reviewed.
Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established. A general database search cannot prove coverage or noncoverage; verify payer, site of service, coding, and local payment assumptions.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
20Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is metadata screening, not a full-paper or systematic literature review. The current discovery snapshot contains 0 PubMed and 0 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, vendor announcement, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 3 history items
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