Radiology AI Directory

FDA-cleared profile

BriefCase

Aidoc Medical, Ltd.

BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel occlusion, cervical-spine fracture-related findings, and pulmonary embolism-related findings for trained professional review.

Pulmonary embolismStroke and ICH triageMSK and boneAcute triage and notification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

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
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel occlusion, cervical-spine fracture-related findings, and pulmonary embolism-related findings for trained professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Appropriately trained medical specialists in hospital networks.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital radiology and acute-care triage workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Case-level triage, notification, and worklist prioritization for supported CT studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported DICOM CT and CTA examinations received through the hospital imaging network.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Case-level notifications, worklist priority, and compressed previews or findings for professional review; original images are not replaced.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
BriefCase is a triage and notification aid, not a standalone diagnosis or rule-out system. Professionals must review the complete source study and follow standard of care; exact indication, acquisition, and single-energy CTPA limits apply.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K203508
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Adult head, brain, cervical spine, pulmonary arteries, and thorax
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-12-29
  • 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 package describes an Aidoc Health Solutions platform, Aidoc Cloud Server, and desktop Worklist receiving, filtering, de-identifying, and returning DICOM-based notifications in a hospital network.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
The FDA package describes an Aidoc Cloud Server plus desktop Worklist and hospital-network workflow; current hosting responsibility, security, availability, and site configuration remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Use by appropriately trained medical specialists in hospital networks. Follow the exact labeling, local training, supervision, and escalation requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K203508.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K203508.

exact submission · checked 2026-09-04
Source

Deployment boundary

The FDA package describes an Aidoc Cloud Server plus desktop Worklist and hospital-network workflow; current hosting responsibility, security, availability, and site configuration remain unknown.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA package describes an Aidoc Health Solutions platform, Aidoc Cloud Server, and desktop Worklist receiving, filtering, de-identifying, and returning DICOM-based notifications in a hospital network.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K203508.

exact submission · checked 2026-09-04
Source

Economic evaluation

Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.

exact submission · checked 2026-09-04
SourceSource

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
K203508 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for BriefCase. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
91.7% (95% CI: 82.7%, 96.9%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
88.6% (95% CI: 81.2%, 93.8%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

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

K203508 FDA evidence package for BriefCase

  • DesignFDA 510(k) decision evidence and product verification for the exact submission.
  • PopulationAdult head, brain, cervical spine, pulmonary arteries, and thorax
  • Scopeexact submission
  • Tested versionBriefCase
  • IndependenceSponsor or vendor study

K203508

FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price or commercial contract for the exact submission and version was identified.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product payer coverage or reimbursement determination was identified in reviewed public material.

No product-specific code

No exact-product reimbursement determination identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.

Source

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
No record matched K203508 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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.

Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads

No evidence was promoted. PMID 41444826 names Aidoc Medical Briefcase ICH Triage but omits the tested software version and K203508; all remaining records are unrelated briefcase alias matches or unrelated trials. The current discovery snapshot contains 20 PubMed and 6 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 & 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 510(k) decision material K203508: BriefCase

    U.S. Food and Drug Administration - Published 2020-12-29 - Accessed 2026-09-04

    Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. BriefCase-C-Spine Fracture Triage model card (K203508)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, reportedSensitivity, reportedSpecificity, 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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K203508 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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