Authorized purpose: Adjunctive opportunistic coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather than a stand-alone diagnosis.
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 coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather than a stand-alone diagnosis.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Adjunctive opportunistic coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather than a stand-alone diagnosis.
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 scans in DICOM format, transferred from an imaging database such as PACS or a DICOM router; the labeled age is 30 years and above.
Who uses it?Intended users: Qualified medical professionals, including radiologists and interpreting physicians.
What does the software produce?Output: An informational visual representation of estimated coronary-artery-calcium segmentation plus exact and four-category quantitative estimates of coronary calcium burden in Agatston units, viewable in the patient report and diagnostic image viewer.
What is its most important limitation?Key limitation: The cleared input is routine non-gated, non-contrast chest CT in patients aged 30 years and above. Results are informational and not intended for stand-alone clinical decision-making; the reviewed FDA validation used paired non-gated chest CT and gated coronary CT studies and should not be generalized beyond the described population and workflow.
Clinical takeaway
Clinical role: Adjunctive opportunistic coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather than a stand-alone diagnosis.
Evidence takeaway
Evidence from the reviewed source record: FDA validation used 762 paired studies from nine geographically diverse sites. Overall category alignment was 79.7%, and category-level positive predictive value ranged from 68.1% to 90.1%; the submission acceptance criteria were at least 73% alignment and at least 65% PPV for each category.
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 coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather than a stand-alone diagnosis.
Adjunctive informational support for radiologist review in the standard workflow; the original patient report and CT remain available and physician review is required.
Adult non-gated, non-contrast chest CT scans in DICOM format, transferred from an imaging database such as PACS or a DICOM router; the labeled age is 30 years and above.
An informational visual representation of estimated coronary-artery-calcium segmentation plus exact and four-category quantitative estimates of coronary calcium burden in Agatston units, viewable in the patient report and diagnostic image viewer.
The cleared input is routine non-gated, non-contrast chest CT in patients aged 30 years and above. Results are informational and not intended for stand-alone clinical decision-making; the reviewed FDA validation used paired non-gated chest CT and gated coronary CT studies and should not be generalized beyond the described population and workflow.
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 standalone SaMD receives DICOM from PACS or a DICOM router and can present the estimated score or category in a patient report, the segmentation in a diagnostic viewer, and an optional DICOM Secondary Capture series.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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.
PACS or DICOM-router input
The cleared standalone SaMD receives routine non-gated, non-contrast chest CT through DICOM transfer from an imaging database such as PACS or a DICOM router and can return report, viewer and optional DICOM Secondary Capture outputs.
Bunkerhill states that its current Carebricks product uses the FDA-cleared iCAC algorithm to detect and quantify CAC on routine non-gated chest CT and describes follow-up prioritization and care coordination for health systems.
product family · checked 2026-09-07
This vendor announcement supports current family workflow context; it does not establish exact K230223 release performance, installation, price, security or support terms.
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
FDA validation used 762 paired studies from nine geographically diverse sites. Overall category alignment was 79.7%, and category-level positive predictive value ranged from 68.1% to 90.1%; the submission acceptance criteria were at least 73% alignment and at least 65% PPV for each category.
DesignRetrospective paired-study validation comparing routine non-gated, non-contrast chest CT estimates with paired gated coronary CT reference categories and Agatston measurements.
Population762 paired CT studies from nine geographically diverse sites, with the calcium categories represented in the validation set.
Scopeexact submission
Tested versioniCAC Device configuration submitted in K230223
Samplen=762
Sites9
IndependenceSponsor or vendor study
K230223
The lower and upper PPV values are endpoints of the reported category span, not a single across-case range metric or a full-paper 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 2026-09-07
No public price or quote for the exact K230223 configuration was reviewed.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
Payer policy research was outside this worker's scope.
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
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
The exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
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 K230223 configuration was reviewed.
Verify reimbursement and coding relevance: Payer policy research was outside this worker's scope.
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.
Verify recalls and postmarket safety signals: The exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
23Fields reviewed
10Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened. The broad iCAC query returned 20 PubMed and 10 trial identifiers without exact K230223 linkage established in metadata; no full paper or trial record was reviewed, and no candidate is promoted as product evidence. The current discovery snapshot contains 20 PubMed and 10 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 history7 sources - 3 history items
cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the...
Careverse CoronaryDoc is a web-based tool for trained medical professionals to view and analyze CCTA CT data for coronary plaques and stenosis, with coronary measurements,...