Radiology AI Directory

FDA-cleared profile

BraveCX

Bering Ltd

Authorized purpose: Passive worklist triage for suspected pleural effusion and/or pneumothorax in adult chest radiographs

Acute 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.

Product overview

Start with the essentials

Authorized purpose: Passive worklist triage for suspected pleural effusion and/or pneumothorax in adult chest radiographs

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Passive worklist triage for suspected pleural effusion and/or pneumothorax in adult chest radiographs

Evidence takeaway

Evidence from the reviewed source record: Internal independent testing used 1,209 pleural-effusion cases and 1,387 pneumothorax cases from 14 acute NHS sites, with three board-certified radiologist ground truths: sensitivity/specificity 82%/95% for pleural effusion and 89%/97% for pneumothorax. External validation used MIMIC-CXR, NIH-CXR, and CheXpert cohorts: pleural effusion n=2,509 with 867 positives, ROC AUC 0.988, sensitivity 92.62%, specificity 98.11%; pneumothorax n=3,245 with 2,114 positives, ROC AUC 0.972, sensitivity 93.38%, specificity 97.27%. Simultaneous prediction time was 4.8-10.4 seconds (95% CI 4.2-10.41 seconds)

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
Passive worklist triage for suspected pleural effusion and/or pneumothorax in adult chest radiographs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Appropriately trained medical specialists qualified to interpret chest radiographs, such as radiologists or other appropriately trained clinicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Adult standard-of-care chest-radiograph worklist; the indication does not restrict the product to a named institutional setting
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Passive notification and prioritization in parallel with standard of care; it does not send a proactive alert, direct attention to image regions, alter the queue, or replace clinical review
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Adult (>=18 years) AP and PA chest X-ray images in DICOM format, received as attached DICOM images or DICOM UIDs referencing stored images
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Case-level flag or blank label for suspected pleural effusion and/or pneumothorax, shown in the PACS/workstation worklist; a newly generated DICOM or JSON result may be stored, with no markup on the original image. The packet also describes a contextual technologist notification within 15 minutes after interpretation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not for standalone clinical decision-making; not a proactive alert; not intended to direct attention to specific image portions or findings other than pleural effusion/pneumothorax; technologist notification is contextual and not for clinical prioritization or action
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K223754
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Chest/lung, targeting pleural effusion and pneumothorax
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-09
  • 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
Licensed API described as deployable cloud-based, on premises, or integrated with third-party systems; supports DICOM storage including PACS or other local storage, produces DICOM/JSON results, and displays worklist flags
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Hybrid
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS and workstation are explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for BraveCX; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

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
Internal independent testing used 1,209 pleural-effusion cases and 1,387 pneumothorax cases from 14 acute NHS sites, with three board-certified radiologist ground truths: sensitivity/specificity 82%/95% for pleural effusion and 89%/97% for pneumothorax. External validation used MIMIC-CXR, NIH-CXR, and CheXpert cohorts: pleural effusion n=2,509 with 867 positives, ROC AUC 0.988, sensitivity 92.62%, specificity 98.11%; pneumothorax n=3,245 with 2,114 positives, ROC AUC 0.972, sensitivity 93.38%, specificity 97.27%. Simultaneous prediction time was 4.8-10.4 seconds (95% CI 4.2-10.41 seconds)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Pleural Effusion: 92.62%, Pneumothorax: 93.38%
  • 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
Pleural Effusion: 98.11%. Pneumothorax: 97.27%
  • 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.

BraveCX regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K223754
  • Samplen=2981
  • IndependenceIndependence not established

K223754

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K223754 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K223754. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
25Fields reviewed
9Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. 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 1 PubMed and 0 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, 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 K223754: BraveCX

    U.S. Food and Drug Administration - Published 2023-11-09 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. BraveCX model card (K223754)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K223754

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K223754 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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