Radiology AI Directory

FDA-cleared profile

ChestView US

Gleamer SAS

Authorized purpose: Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.

X-ray/Radiography workflow
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: Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.

Evidence takeaway

Evidence from the reviewed source record: The FDA packet defines the annotated outputs and intended thoracic findings but the reviewed summary did not yield a single consolidated performance number suitable for this dossier.

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
Concurrent reading aid for adult frontal and lateral chest radiographs, marking suspected nodules, pleural-space abnormalities, mediastinal/hilar abnormalities and consolidations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Radiologists, emergency physicians and other qualified healthcare professionals interpreting adult chest radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Hospital and outpatient imaging services using adult frontal and lateral chest radiography.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Concurrent reading aid that presents annotated output for radiologist or emergency-physician review; final interpretation remains with the clinician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
Adult frontal and lateral chest X-ray examinations received as DICOM; the submission describes the cleared thoracic regions and listed findings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
Annotated DICOM output with boxes labeled Nodule, Pleural space abnormality, Mediastinum/Hila abnormality and Consolidation. Solid-line boxes indicate higher specificity and dotted-line boxes indicate higher sensitivity; NO CHESTVIEW ROI and OUT OF SCOPE states are also displayed.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
The product is an aid and does not replace clinician interpretation. Output labels include NO CHESTVIEW ROI and OUT OF SCOPE when the algorithm cannot provide a relevant result; the cleared scope is adult frontal/lateral chest radiography and listed findings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

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
K241620
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-02-27
  • 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
DICOM chest radiographs are processed and returned with annotated output for review in the radiology workflow; exact local worklist and PACS routing require site confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
The FDA submission describes a software workflow that receives chest radiographs and returns annotated DICOM images; the public summary does not establish a particular hosting model.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

The reviewed public sources do not establish exact-release security controls, retention or assurance documentation.

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.

Annotated DICOM findings

The cleared output adds labeled boxes and explicit NO CHESTVIEW ROI or OUT OF SCOPE states for clinician review.

exact submission · checked 2026-09-07
Source

Worklist and shadow-mode workflow

The current ChestView family page describes native workflow integration, worklist support and shadow-mode evaluation for deployment planning.

product family · checked 2026-09-06

These family capabilities do not establish exact K241620 hosting, performance or service terms.

Source

Current family label reference

Gleamer publishes a ChestView v1.0.1-US label with current product-family scope and labeling information.

product family · checked 2026-09-06

The public label was not used to overwrite the K241620 FDA submission identity.

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
The FDA packet defines the annotated outputs and intended thoracic findings but the reviewed summary did not yield a single consolidated performance number suitable for this dossier.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
95%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Reported specificity
95%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

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

ChestView US K241620 validation

  • DesignRegulatory performance validation described in the FDA 510(k) summary
  • PopulationAdult frontal and lateral chest radiographs with the listed thoracic findings
  • Scopeexact submission
  • Tested versionChestView US configuration submitted in K241620
  • IndependenceSponsor or vendor study

K241620

The dossier retains the cleared outputs and limitations without inventing a consolidated sensitivity or specificity value.

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 2026-09-07

No public price or quote for ChestView US was reviewed.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

Payer policy research was not part of this worker's scope.

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 2026-09-07

The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

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
2026-09-07Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, fda decision summary, acr ai central product, vendor product page, vendor label, stored candidate metadata, 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 510(k) K241620: ChestView US

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. ChestView US model card (K241620)

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

    Scope: intendedUsers, careSetting, output, 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. ChestView | Gleamer

    Gleamer - Accessed 2026-09-06

    Scope: productFamilyContext, clinicalUse, implementationCapabilities

  8. ChestView v1.0.1-US label

    Gleamer - Accessed 2026-09-06

    Scope: productVersion, productFamilyContext

Research history

  1. K241620 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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