Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
BriefCase
Aidoc Medical, Ltd.
Authorized purpose: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial hemorrhage (ICH) pathologies. Briefcase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
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: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial hemorrhage (ICH) pathologies. Briefcase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial hemorrhage (ICH) pathologies. Briefcase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain Input: Non-enhanced CT scan of the head or neck
- Who uses it? Intended users: Hospital networks and appropriately trained medical specialists
- What does the software produce? Output: The AI model flags and sends notifications to a standalone desktop application for cases with suspected intracranial hemorrhage (ICH) findings. Notifications include compressed, low-quality, grayscale, unannotated preview images for informational/triage purposes only (not for diagnostic use). The device facilitates worklist prioritization by alerting clinicians to suspected positive ICH cases.
- What is its most important limitation? Key limitation: Non-enhanced head or neck CT protocol with a 64-slice scanner or higher; scans performed on adults/transitional adults ≥ 18 years of age; slice thickness 0.625 mm – 5.0 mm. All scans that are technically inadequate, including motion artifacts, severe metal artifacts, suboptimal bolus timing or an inadequate field of view.
Clinical takeaway
Clinical role: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial hemorrhage (ICH) pathologies. Briefcase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Evidence takeaway
Evidence from the reviewed source record: Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase software to evaluate the software's performance in identifying non-contrast head CT images containing intracranial hemorrhage (ICH) in 220 cases from 5 US-based clinical sites. Sensitivity was 96.15% (95% CI: 90.44%, 98.94%) and specificity was 94.83% (95% CI: 89.08%, 98.08%).
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 is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Intracranial hemorrhage (ICH) pathologies. Briefcase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
- Intended users
- Hospital networks and appropriately trained medical specialists
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Non-enhanced CT scan of the head or neck
The subject-device table states the data acquisition protocol.
- Output and human action
- The AI model flags and sends notifications to a standalone desktop application for cases with suspected intracranial hemorrhage (ICH) findings. Notifications include compressed, low-quality, grayscale, unannotated preview images for informational/triage purposes only (not for diagnostic use). The device facilitates worklist prioritization by alerting clinicians to suspected positive ICH cases.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- Non-enhanced head or neck CT protocol with a 64-slice scanner or higher; scans performed on adults/transitional adults ≥ 18 years of age; slice thickness 0.625 mm – 5.0 mm. All scans that are technically inadequate, including motion artifacts, severe metal artifacts, suboptimal bolus timing or an inadequate field of view.
The exact packet's comparison table states the subject-device inclusion and exclusion boundary and slice thickness.
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
- K221240
- Modality
- CT/CTA
The exact indication specifies non-enhanced head CT images and does not establish CTA. Controlled directory display reconciled from exact FDA wording: Non-enhanced head CT -> CT/CTA.
- Anatomy
- Brain
The subject-device table states the anatomical region of interest as Head. Controlled directory display reconciled from exact FDA wording: Head -> Brain.
- Clearance type
- 510(k)
- Decision date
- 2022-05-17
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
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; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase software to evaluate the software's performance in identifying non-contrast head CT images containing intracranial hemorrhage (ICH) in 220 cases from 5 US-based clinical sites. Sensitivity was 96.15% (95% CI: 90.44%, 98.94%) and specificity was 94.83% (95% CI: 89.08%, 98.08%).
The exact packet reports the study population and exact primary endpoint metrics.
- Reported sensitivity
- 96.15%
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 94.83%
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.
BriefCase-Intracranial Hemorrhage Triage regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K221240
- Samplen=220
- Sites5
- IndependenceIndependence not established
K221240
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K221240 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K221240. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K221240 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
28Fields reviewed
10Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 20 PubMed and 6 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. 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 device recall, literature index, trial registry, fda decision summary packet, 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
-
FDA K221240: BriefCase
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, output, input, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BriefCase-Intracranial Hemorrhage Triage model card (K221240)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K221240
Scope: postmarketSafety
Research history
-
K221240 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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