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 non-enhanced CT and CTPA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
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 non-enhanced CT and CTPA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
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 non-enhanced CT and CTPA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain; Chest/Lung Input: non-enhanced head CT and CTPA images; for the PE pathology, the software is only intended to be used on single-energy exams.
- Who uses it? Intended users: Radiologist
- What does the software produce? Output: Triage and flag suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies.
- What is its most important limitation? Key limitation: 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.
Clinical takeaway
Clinical role: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced CT and CTPA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
Evidence takeaway
Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 184. Sites: 3. Reported sensitivity: 90.6% (95% CI: 82.2%-95.9%). Reported specificity: 89.9% (95% CI: 82.2%-95.1%)
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 non-enhanced CT and CTPA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
- Intended users
- Radiologist
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- non-enhanced head CT and CTPA images; for the PE pathology, the software is only intended to be used on single-energy exams.
The exact indication states the two image types and the single-energy boundary for PE.
- Output and human action
- Triage and flag suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- 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 exact indication states the preview-image, diagnostic-use, and unchanged-image boundaries.
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
- K190072
- Modality
- CT/CTA
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Brain; Chest/Lung
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2019-04-15
- 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
- Study type: Stand-Alone Performance. Cases: 184. Sites: 3. Reported sensitivity: 90.6% (95% CI: 82.2%-95.9%). Reported specificity: 89.9% (95% CI: 82.2%-95.1%)
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Reported sensitivity
- 90.6% (95% CI: 82.2%-95.9%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 89.9% (95% CI: 82.2%-95.1%)
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-ICH and PE triage regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K190072
- Samplen=184
- Sites3
- IndependenceIndependence not established
K190072
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 K190072 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 K190072. 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 care setting and population: Confirm the intended care setting, patient population, and service line.
- 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 K190072 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
26Fields 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 K190072: BriefCase
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, output, evidenceSummary, input, limitations
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
BriefCase-ICH and PE triage model card (K190072)
Scope: intendedUsers, 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 K190072
Scope: postmarketSafety
Research history
-
K190072 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
Alternatives
Related tools to compare
FDA-cleared K203508
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...
- Modality
- CT/CTA
- Anatomy
- Adult head, brain, cervical spine, pulmonary arteries, and thorax
- Decision
- 2020-12-29
FDA-cleared K252421
JLK-NCCT
JLK, Inc.
Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...
- Modality
- CT/CTA
- Anatomy
- Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
- Decision
- 2026-03-24
FDA-cleared K250694
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.
- Modality
- CT/CTA
- Anatomy
- Brain/Head
- Decision
- 2025-11-25
FDA-cleared K251983
Brainomix 360 Triage Stroke
Brainomix Limited
Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.
- Modality
- CT/CTA
- Anatomy
- Brain/head, including intracranial ICA and M1 for LVO and intracranial hemorrhage findings
- Decision
- 2025-08-26