Authorized purpose: BriefCase analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the carina; it flags tip positions more than 5 cm above, less than 2 cm above, or below the carina and requires standard-of-care image review.
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 analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the carina; it flags tip positions more than 5 cm above, less than 2 cm above, or below the carina and requires standard-of-care image review.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: BriefCase analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the carina; it flags tip positions more than 5 cm above, less than 2 cm above, or below the carina and requires standard-of-care image review.
Which images or clinical context are in scope?Modality: X-ray/Radiography Anatomy or clinical context: Chest/Lung Input: Frontal chest X-ray in DICOM 3.0 from compatible X-ray scanners; the carina must be well visualized for a result.
Who uses it?Intended users: Appropriately trained medical specialists in hospital networks; the notification supports triage while full-image review and professional judgment remain required.
What does the software produce?Output: Desktop triage notification for suspected vertical ETT malposition with a compressed, unannotated grayscale preview labeled not for diagnostic use; the original image remains unchanged.
What is its most important limitation?Key limitation: The device assesses only vertical ETT-tip position relative to the carina, does not factor patient positioning, cannot detect esophageal intubation, provides no result when the carina is not well visualized, and may falsely alert on a properly positioned double-lumen ETT; the notification is informational and not diagnostic.
Clinical takeaway
Clinical role: BriefCase analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the carina; it flags tip positions more than 5 cm above, less than 2 cm above, or below the carina and requires standard-of-care image review.
Evidence takeaway
Evidence from the reviewed source record: A retrospective, blinded, multicenter pivotal study evaluated 921 cases from 5 US clinical sites against a 2-of-3 majority reference of senior board-certified radiologists. Sensitivity was 86.81% and specificity 92.02%; BriefCase time-to-notification was 4.93 minutes in 182 true-positive cases.
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 frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the carina; it flags tip positions more than 5 cm above, less than 2 cm above, or below the carina and requires standard-of-care image review.
Appropriately trained medical specialists in hospital networks; the notification supports triage while full-image review and professional judgment remain required.
Desktop triage notification for suspected vertical ETT malposition with a compressed, unannotated grayscale preview labeled not for diagnostic use; the original image remains unchanged.
The device assesses only vertical ETT-tip position relative to the carina, does not factor patient positioning, cannot detect esophageal intubation, provides no result when the carina is not well visualized, and may falsely alert on a properly positioned double-lumen ETT; the notification is informational and not diagnostic.
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 exact system comprises Aidoc Hospital Server/Orchestrator for image acquisition, Aidoc Cloud Server for processing, and Aidoc Desktop Application for workflow integration. DICOM images are received, filtered, and de-identified before processing, with notifications sent to the desktop application and shared PACS workflows supported.
The reviewed sources do not establish a scoped security audit, certification, or control set.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Training, credentialing, and implementation support terms were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Current post-deployment monitoring and change-control practices were not established.
DICOM/PACS/cloud triage workflow
The exact submission describes DICOM 3.0-compatible X-ray scanners, PACS and radiology workstations, Aidoc Hospital Server acquisition, Aidoc Cloud Server processing, and Aidoc Desktop workflow integration with filtered/de-identified image handling.
Aidoc's current official radiology page lists ETT malposition among radiology solutions and describes a Widget interface with key images/summary, workstation access, PACS worklist integration, and care-team communication; current family capabilities are not assumed to prove the exact K221330 build.
product family · checked 2026-09-07
Current family workflow context only; exact-version compatibility requires confirmation.
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
A retrospective, blinded, multicenter pivotal study evaluated 921 cases from 5 US clinical sites against a 2-of-3 majority reference of senior board-certified radiologists. Sensitivity was 86.81% and specificity 92.02%; BriefCase time-to-notification was 4.93 minutes in 182 true-positive cases.
BriefCase vertically malpositioned ETT pivotal validation
DesignRetrospective blinded multicenter validation against a 2-of-3 majority senior board-certified radiologist reference
Population921 frontal chest X-ray cases from 5 US clinical sites; time-to-notification analysis included 182 true-positive cases.
Scopeexact submission
Tested versionBriefCase vertically malpositioned ETT triage submitted in K221330; build not stated
Samplen=921
Sites5
IndependenceIndependence not established
K221330
The FDA states that pivotal cases were distinct in time or center from training cases. That establishes dataset separation, not independent investigators or sponsorship.
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 amount, range, currency, geography, or contract term was established.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer or CMS policy review was performed in this worker cohort.
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 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: The reviewed sources do not establish a scoped security audit, certification, or control set.
Verify training: Training, credentialing, and implementation support terms were not established.
Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
Verify local validation and lifecycle monitoring: Current post-deployment monitoring and change-control practices were not established.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
26Fields reviewed
10Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed, ClinicalTrials.gov, and exact-submission recall metadata candidates were screened by identifier and count. The records were not treated as a full paper, trial, or postmarket review. 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, vendor product page, literature index, trial registry, 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 history7 sources - 3 history items
Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.
Passive triage of adult AP chest radiographs for an endotracheal-tube tip more than 7 cm above the carina, less than 3 cm above the carina, below the carina in the right or left...
Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...