Radiology AI Directory

FDA-cleared profile

BriefCase-Quantification

Aidoc Medical, Ltd.

Authorized purpose: Four-category coronary artery calcification (CAC) assessment of plaques on non-cardiac-gated, non-contrast CT images that include the heart; preview images are informational and the result is not for stand-alone clinical decision-making.

Cardiac imaging
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: Four-category coronary artery calcification (CAC) assessment of plaques on non-cardiac-gated, non-contrast CT images that include the heart; preview images are informational and the result is not for stand-alone clinical decision-making.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Four-category coronary artery calcification (CAC) assessment of plaques on non-cardiac-gated, non-contrast CT images that include the heart; preview images are informational and the result is not for stand-alone clinical decision-making.

Evidence takeaway

Evidence from the reviewed source record: FDA packet: retrospective, blinded, multicenter pivotal study of 433 cases from 6 U.S. clinical sites, with ground truth finalized by a senior U.S. board-certified radiologist when reviewers disagreed. Overall CAC-category agreement was 87.1%; category agreement was very low 95.1%, low 81.3%, medium 81.5%, and high 89.3%. These are agreement endpoints; the packet does not report sensitivity, specificity, or AUC.

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
Four-category coronary artery calcification (CAC) assessment of plaques on non-cardiac-gated, non-contrast CT images that include the heart; preview images are informational and the result is not for stand-alone clinical decision-making.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and appropriately trained medical specialists (physicians).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Hospital-network clinical workflow for adults aged 30 years and older; the FDA packet does not name a narrower facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel post-processing CAC categorization, quantification, and visualization support for clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Filtered routine DICOM images from non-cardiac-gated, non-contrast CT studies that include the heart in adults aged 30 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Very low, low, medium, or high CAC category corresponding to Agatston ranges 0, 1-100, 101-400, and at least 400; a preliminary report with warnings, category, and number of CAC-containing slices; and PACS images showing the represented calcium alongside original slices.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Technically inadequate studies, including motion artifacts, severe metal artifacts, or suboptimal/inadequate field of view, are excluded; the comparison table lists axial slice thickness up to 5.0 mm and a 130 HU calcium threshold. Results are preliminary, preview images are non-diagnostic, and clinicians must review full images and other clinical information; the device is not for stand-alone decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K231631
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Heart and coronary arteries
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-28
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The FDA packet describes filtered DICOM CT input to a Linux-based cloud server and transfer of analysis to PACS or a desktop image-review application; exact local interface versions and compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for BriefCase-Quantification; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท checked 2026-09-09
Source

Evidence

Performance evidence

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 packet: retrospective, blinded, multicenter pivotal study of 433 cases from 6 U.S. clinical sites, with ground truth finalized by a senior U.S. board-certified radiologist when reviewers disagreed. Overall CAC-category agreement was 87.1%; category agreement was very low 95.1%, low 81.3%, medium 81.5%, and high 89.3%. These are agreement endpoints; the packet does not report sensitivity, specificity, or AUC.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

BriefCase-Quantification for Coronary Artery Calcification (CAC) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231631
  • Samplen=433
  • Sites6
  • IndependenceIndependence not established

K231631

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

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 2026-09-09

No public price or quote for the exact K231631 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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-identifier FDA recall query returned no native recall record for K231631. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-20Last searched
22Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, fda device recall, 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 history

Source ledger

  1. FDA K231631: BriefCase-Quantification

    U.S. Food and Drug Administration - Published 2023-11-28 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. BriefCase-Quantification for Coronary Artery Calcification (CAC) model card (K231631)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K231631

    U.S. Food and Drug Administration - Accessed 2026-09-09

    Scope: postmarketSafety

Research history

  1. K231631 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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