Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
SmartChest
Milvue
Authorized 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.
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: 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.
Overview status: Source-reviewed overview
- What does this software do? Authorized 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.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Chest/lung 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.
- Who uses it? Intended users: Appropriately trained medical specialists qualified to interpret chest radiographs
- What does the software produce? Output: 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.
- What is its most important limitation? Key limitation: 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.
Clinical takeaway
Clinical role: 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.
Evidence takeaway
Evidence from the reviewed source record: 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.
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.
- Intended users
- Appropriately trained medical specialists qualified to interpret chest radiographs
- Care setting and population
- Standard-of-care chest-radiography workflow using a PACS or worklist; facility type is not specified in the FDA packet
- 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.
- 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.
- 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.
- 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.
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.
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.
- Deployment and data flow
- Hybrid
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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 2026-09-08Evidence
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.
- Reported sensitivity
- Pneumothorax: 92.7% (95% CI 87.4%-96.2%); pleural effusion: 93.3%.
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%.
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.
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
No public price or quote for the exact K232410 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K232410 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external 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, 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
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FDA K232410: SmartChest
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
SmartChest model card (K232410)
Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K232410
Scope: postmarketSafety
Research history
-
K232410 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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