Chest CT (with or without contrast) triage and notification for suspected three or more acute rib fractures in adults or transitional adolescents age 18 or older; notifications are non-diagnostic and clinicians review the original study.
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
Chest CT (with or without contrast) triage and notification for suspected three or more acute rib fractures in adults or transitional adolescents age 18 or older; notifications are non-diagnostic and clinicians review the original study.
Computer-aided triage and notification: a suspect case generates a desktop pop-up and unannotated compressed preview while the original worklist and standard-of-care interpretation continue.
A desktop notification for a suspected RibFx case and a compressed, low-quality, grayscale, unannotated preview captioned for prioritization only; the original medical image is not altered.
The preview and notification are informational and not for diagnostic use beyond notification. Clinicians must review the full original images in PACS with other patient information and professional judgment; the device does not remove or deprioritize cases from the worklist.
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
Uses DICOM CT input, an image communication or routing platform for acquisition, an algorithm module for processing, and a desktop application/feed with a non-diagnostic viewer for workflow integration; clinicians return to the local PACS for full-image review.
The exact FDA description places the algorithm on a Linux-based server in a cloud environment and describes processing through a compatible image communication platform before notification reaches the desktop application.
FDA source
Exact FDA submission
Checked 2026-09-07
This is the submission-era architecture; current tenant, hosting, security and contract terms require vendor confirmation.
Cloud architecture language does not establish formal security controls for a current installed configuration.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Exact DICOM triage and notification path
The exact FDA record describes filtered DICOM CT acquisition, algorithm processing, and a desktop feed/preview that prompts review of the original study in local PACS without changing or deprioritizing the standard worklist.
Aidoc's current radiology page describes deep integrations with EHR, PACS, scheduling and reporting; its Widget runs on the workstation and places AI triage results directly in the worklist with key images and a summary of AI results.
product family · checked 2026-09-07
Current family platform context is buyer-relevant but does not establish the exact K230020 tenant, release or contractual interfaces.
Aidoc's official Atlantic Health announcement describes deployment across several hospitals, where physicians use Aidoc AI to triage CT scans and receive alerts for potential rib fractures and other findings.
product family · checked 2026-09-07
This is a vendor-reported family deployment example, not evidence that the exact K230020 configuration was installed there.
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
K230020's exact FDA pivotal study evaluated 308 chest CT cases at five U.S. sites against majority-vote ground truth from three senior board-certified radiologists. The study reported observed AUC, sensitivity, specificity and notification-time results; its performance goals were thresholds and are kept separate from the observed values.
DesignRetrospective, blinded, multicenter FDA submission study comparing BriefCase with ground truth from three senior board-certified radiologists using majority voting.
Population308 chest CT cases from five U.S.-based clinical sites; cases were distinct in time or center from training data.
Scopeexact submission
Tested versionBriefCase rib-fracture triage release reviewed in FDA submission K230020
Samplen=308
Sites5
IndependenceIndependence not established
K230020
The FDA summary reports the study and vendor submission; independent-investigator status was not established.
Assessment of a deep learning algorithm for the automatic detection of rib fractures on trauma CTs
DesignRetrospective trauma-CT prototype evaluation described on an official Aidoc clinical-study page.
Population511 trauma CTs from an emergency-department dataset collected January through December 2018; the page describes 102 positive and 409 negative cases by clinical report.
Scopeproduct family
Tested versionAidoc rib-fracture prototype; the page does not identify it as the exact K230020 release.
Samplen=511
IndependenceIndependence not established
Aidoc official clinical study page
The page reports 75 fractures not mentioned in written reports and potential reading assistance. This family/prototype evidence must not be used as K230020 release performance.
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 2026-09-07
No public exact-submission price or procurement terms were reviewed.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
CMS policy research was not performed by this worker; no coverage conclusion is made.
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: Cloud architecture language does not establish formal security controls for a current installed configuration.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public exact-submission price or procurement terms were reviewed.
Verify reimbursement and coding relevance: CMS policy research was not performed by this worker; no coverage conclusion is made.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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
13Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials candidate metadata were screened in the exact stored order; this was metadata triage, not full-text paper or registry-record review, and no candidate was promoted. The stored recall query returned no records, so no event was promoted and no absence claim is made. 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, vendor clinical study, vendor press release, literature index, trial registry, stored candidate metadata, stored recall candidates, 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 history10 sources - 2 history items
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