Radiology AI Directory

FDA-cleared profile

SmartChest

Milvue

Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22 years and older; not diagnostic or a rule-out function.

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
Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22 years and older; not diagnostic or a rule-out function.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Appropriately trained medical specialists qualified to interpret chest radiographs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Standard-of-care chest-radiography workflow using a PACS or worklist; facility type is not specified in the FDA packet
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Passive notification and worklist prioritization in parallel with standard of care; the device does not send a proactive alert, reorder or remove cases, or direct attention to a specific image location.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Frontal PA or AP chest X-ray images from transitional adolescents aged 18-21 and adults aged 22 years and older, received from PACS or other DICOM storage; lateral views and excluded ages are not processed.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A newly generated DICOM secondary-capture series with study-level status and tags such as CASE PROCESSED, NOT PROCESSED, SUSPECTED FINDING, SUSPECTED PLEURAL EFFUSION, and SUSPECTED PNEUMOTHORAX, plus the number of images received and processed.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Prioritization only; the contextual notification is not diagnostic, is not intended for standalone clinical decision-making, and is not a rule-out result. Unflagged studies still require specialist interpretation, the device does not direct attention to a specific image portion, and out-of-scope views or ages are not processed.
  • 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
K232410
  • 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
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-05-10
  • 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
Chest radiographs are automatically received from PACS or other DICOM storage and results are passively returned as a new DICOM series to the worklist platform. The packet describes local and cloud server execution contexts but does not establish a specific PACS/RIS interface, version, or current deployment model.
  • 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

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for SmartChest; 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
FDA K232410 reports two independent standalone performance assessments, each using 300 US chest X-ray cases and a reference standard formed by majority consensus of three ABR-certified cardiothoracic radiologists. For pneumothorax, AUC was 0.989, sensitivity 92.7% (95% CI 87.4-96.2), and specificity 97.3% (95% CI 93.4-99.1). For pleural effusion, AUC was 0.975 (95% CI 0.960-0.987), sensitivity 93.3% (95% CI 88.1-96.4), and specificity 90.0% (95% CI 84.1-94.1). Execution time was reported separately for local and cloud servers.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Pneumothorax: 92.7% (95% CI 87.4%-96.2%); pleural effusion: 93.3%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Condition-specific FDA endpoints are retained separately rather than collapsed into one device-level pair.

Reported specificity
Pneumothorax: 97.3% (95% CI 93.4%-99.1%); pleural effusion: 90.0%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Condition-specific FDA endpoints are retained separately rather than collapsed into one device-level pair.

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

SmartChest regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K232410
  • Samplen=300
  • IndependenceIndependence not established

K232410

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 K232410 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 K232410. 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
2026-09-08Last 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 K232410: SmartChest

    U.S. Food and Drug Administration - Published 2024-05-10 - 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. SmartChest model card (K232410)

    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 K232410

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

    Scope: postmarketSafety

Research history

  1. K232410 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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