qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura, mediastinum/hila/heart, bone, hardware and other categories; trained clinicians remain responsible for primary interpretation.
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
qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura, mediastinum/hila/heart, bone, hardware and other categories; trained clinicians remain responsible for primary interpretation.
Concurrent-reading adjunct for adult chest radiographs only; it does not replace the trained clinician's primary image interpretation. PCCP authorization does not establish performance of every later model update.
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
qXR client software sends de-identified radiographs to the service through HTTPS, and results are passed to the client for transfer to PACS or another receiving system.
The FDA summary describes a secure cloud-server deployment with de-identified radiographs transmitted via HTTPS client software; its comparison table also describes on-premises or cloud deployment.
FDA source
Exact FDA submission
Checked 2026-09-06
This does not establish an installed site's hosting, data-residency or security-control configuration.
The label's HTTPS/de-identification data-flow description is not a formal, dated and scoped security assessment.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-06
Trained-user intent does not establish a verified current training program.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-06
No verified monitoring service was found. Site acceptance should evaluate image eligibility, result routing, reader interaction and failure fallback.
Current qXR-Detect family announcement
Qure.ai's February 2026 announcement describes qXR-Detect as identifying, highlighting and categorizing positive findings on chest X-rays and identifies the device as a CADe radiography solution.
product family · checked 2026-09-06
Commercial announcement context only; exact intended use, version and performance are sourced to K251934.
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
The manufacturer MRMC study included 301 cases and 18 readers. It evaluated aided versus unaided reader performance for the study's composite chest-radiograph endpoint.
The reviewed summary reports category and composite performance, but a single general diagnostic sensitivity is not appropriate for this multi-finding CADe device.
Reported specificity
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-06
The reviewed summary does not establish one general diagnostic specificity across the heterogeneous finding categories.
Aided weighted AFROC
0.7505 weighted AFROC
EndpointReader performance with qXR-Detect assistance in the MRMC study
Population301 adult chest-radiograph cases interpreted by 18 readers
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 2026-09-06
No public exact-version price or procurement record reviewed.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-06
No applicable CMS policy content reviewed; 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: The label's HTTPS/de-identification data-flow description is not a formal, dated and scoped security assessment.
Verify training: Trained-user intent does not establish a verified current training program.
Verify pricing and total cost: No public exact-version price or procurement record reviewed.
Verify reimbursement and coding relevance: No applicable CMS policy content reviewed; no coverage conclusion is made.
Verify local validation and lifecycle monitoring: No verified monitoring service was found. Site acceptance should evaluate image eligibility, result routing, reader interaction and failure fallback.
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
2026-09-06Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored PubMed and ClinicalTrials candidate metadata snapshots were screened; both arrays were empty. No candidate evidence was promoted. The current discovery snapshot contains 0 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, acr ai central product, fda decision summary, vendor product page, 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 history7 sources - 2 history items
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