Radiology AI Directory

FDA-cleared profile

qXR-PTX-PE

Qure.ai Technologies

Analyze adult frontal chest X-ray images for suspected pleural effusion and/or pneumothorax and provide case-level passive output for PACS/workstation worklist prioritization or triage within standard of care; results are not for standalone clinical decision-making or to rule out the target conditions.

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.

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
Analyze adult frontal chest X-ray images for suspected pleural effusion and/or pneumothorax and provide case-level passive output for PACS/workstation worklist prioritization or triage within standard of care; results are not for standalone clinical decision-making or to rule out the target conditions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Appropriately trained medical specialists, including radiologists, clinicians, and other specialists qualified to read chest radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Adult chest-radiograph routine-of-care worklist; the FDA test data came from multiple U.S. hospitals, but the packet does not specify a required facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Passive, case-level notification and prioritization in a PACS/workstation; it does not send a proactive alert and does not alter the original image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Frontal adult chest X-rays, AP or PA views, in DICOM format, received through a user image-storage system such as PACS or other radiological imaging equipment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Passive worklist notification for suspected pneumothorax and/or pleural effusion, with a secondary capture indicating the suspicious finding; no markup is placed on the original image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The FDA indication is limited to adult frontal chest X-ray images and the two prespecified findings. Results are not standalone diagnostic decisions, do not rule out the findings, do not direct attention to image portions, and do not provide proactive alerts.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K230899
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-08-22
  • 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
The FDA packet describes DICOM input through PACS or other radiological equipment and result display in a PACS/workstation or DICOM viewer; exact current interfaces, versions, and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • 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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

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

exact submission · checked 2026-09-09
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
Pneumothorax testing used 613 scans (201 positive, 412 negative) with ground truth from three ABR thoracic radiologists: AUC 98.94% (95% CI 98.28%-99.82%), sensitivity 94.53% (90.42%-97.24%), and specificity 96.36% (94.07%-97.95%). Pleural-effusion testing used 1,070 scans (344 positive, 726 negative): AUC 98.90% (98.47%-99.44%), sensitivity 96.22% (93.62%-97.97%), and specificity 94.90% (93.04%-96.39%). These condition-specific AUC, sensitivity, and specificity endpoints are distinct; average analysis-to-worklist performance time was 10 seconds.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
FDA standalone sensitivity: pneumothorax 94.53% (95% CI 90.42%-97.24%; 190/201 positive scans) and pleural effusion 96.22% (95% CI 93.62%-97.97%; 331/344 positive scans).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA reports separate condition-specific sensitivity endpoints; the baseline 95% is not a supported overall value, and AUC and 10-second performance time are separate endpoints.

Reported specificity
FDA standalone specificity: pneumothorax 96.36% (95% CI 94.07%-97.95%; 397/412 negative scans) and pleural effusion 94.90% (95% CI 93.04%-96.39%; 689/726 negative scans).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA reports separate condition-specific specificity endpoints; predicate-device values and AUC must not be merged with the subject-device specificity.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

qXR-PTX-PE regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K230899
  • IndependenceIndependence not established

K230899

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 2026-09-09

No public price or quote for the exact K230899 configuration was established in this review.

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

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 K230899. 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 2026-09-09

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
2026-09-09Last searched
24Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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 K230899: qXR-PTX-PE

    U.S. Food and Drug Administration - Published 2023-08-22 - Accessed 2026-09-09

    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. qXR-PTX-PE model card (K230899)

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

    Scope: careSetting, output, limitations, 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 K230899

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

    Scope: postmarketSafety

Research history

  1. K230899 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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