Radiology AI Directory

FDA-cleared profile

qXR-LN

Qure.ai Technologies

Authorized purpose: Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population

Lung nodule detectionDetection and CADe
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: Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population

Evidence takeaway

Evidence from the reviewed source record: Standalone study covered 8 states and 40 US sites, with ground truth from five ABR-certified readers using chest radiographs plus CT and reports. qXR-LN nodule-level sensitivity was 84.1% (reported CI 77.97%-97.24%) and FPPI 0.18 (0.14-0.22). Scan-level AUC was 94.51 (92.64-96.66), sensitivity 93.83 (88.94-97.00), and specificity 81.09 (76.30-85.00). In the MRMC second-read study, AFROC was 0.8095 aided versus 0.7333 unaided, delta 0.07621, p<1e-5; nodule-level sensitivity improvement was 11.96 percentage points

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
Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists, emergency-room physicians, or pulmonologists who regularly review chest X-rays
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Incidental adult chest-radiograph review in routine clinical workflow; the packet does not restrict the product to a named institutional setting
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Second-reader CADe detection and localization, operating as an adjunct to physician review rather than standalone clinical decision-making
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM frontal AP or PA digital chest radiographs of adults; effective target nodule size 6-30 mm
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
DICOM output with ROI markings on a duplicated input image showing the presence and location of suspected pulmonary nodules; output is for adjunctive review and does not rule out the target condition
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Incidental adult population and frontal AP/PA digital chest radiographs only; target range 6-30 mm; adjunctive second-reader information, not standalone clinical decision-making and not a substitute for the original radiograph
  • 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
K231805
  • 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, focused on suspected pulmonary nodules
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-12-22
  • 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
Images are sent through a PACS or other radiological image-storage system, and the device is intended for use with any DICOM viewer or PACS; exact local interface/version compatibility is not established
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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 2026-09-08

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

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for qXR-LN; 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
Standalone study covered 8 states and 40 US sites, with ground truth from five ABR-certified readers using chest radiographs plus CT and reports. qXR-LN nodule-level sensitivity was 84.1% (reported CI 77.97%-97.24%) and FPPI 0.18 (0.14-0.22). Scan-level AUC was 94.51 (92.64-96.66), sensitivity 93.83 (88.94-97.00), and specificity 81.09 (76.30-85.00). In the MRMC second-read study, AFROC was 0.8095 aided versus 0.7333 unaided, delta 0.07621, p<1e-5; nodule-level sensitivity improvement was 11.96 percentage points
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
93.83% (95% CI: 88.94%, 97%)
  • 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
81.09% (95% CI: 76.30%, 85%)
  • 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.

qXR-LN regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231805
  • Sites40
  • IndependenceIndependence not established

K231805

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 K231805 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 K231805. 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
0Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 0 PubMed and 2 ClinicalTrials.gov candidate records. 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 0 PubMed and 2 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 K231805: qXR-LN

    U.S. Food and Drug Administration - Published 2023-12-22 - 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. qXR-LN model card (K231805)

    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 K231805

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

    Scope: postmarketSafety

Research history

  1. K231805 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

Alternatives

Related tools to compare

FDA-cleared K223133

VisiRad XR

Imidex Inc.

VisiRad XR is a computer-aided detection device that identifies and marks regions of interest suspicious for lung nodules and masses measuring 6-60 mm on chest radiographs in...

Modality
X-ray/Radiography
Anatomy
Adult chest and pulmonary nodules or masses 6-60 mm
Decision
2023-08-03
Lung nodule detectionDetection and CADe
FDA-approved P000041

RAPIDSCREEN RS-2000

RIVERAIN MEDICAL GROUP

RAPIDSCREEN RS-2000 is a PMA-authorized computer-aided detection device that identifies and marks regions of interest on digitized frontal chest radiographs associated with...

Modality
X-ray/Radiography
Anatomy
Adult chest; solitary pulmonary nodules 9-30 mm
Decision
2001-07-12
Lung nodule detectionDetection and CADe
FDA-cleared K252953

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth...

Modality
X-ray/Radiography
Anatomy
Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
Decision
2026-05-11
MSK and boneDetection and CADe
FDA-cleared K253502

Critical Care Suite with Enteric Tube Positioning AI Algorithm

Ge Medical Systems, LLC

Analyze frontal chest and abdominal X-ray images to detect and localize a nasally or orally inserted enteric tube, its tip and side port if present, and the diaphragm and airways...

Modality
X-ray/Radiography
Anatomy
Chest/lung and abdomen/stomach; enteric tube, tube tip and side port, diaphragm, and airways including carina and left/right bronchi
Decision
2026-04-14
Detection and CADe