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
IQ-UIP
Imbio, Inc.
Authorized purpose: Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not diagnosis.
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 referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not diagnosis.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not diagnosis.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest/lungs, specifically radiological usual interstitial pneumonia pattern Input: Non-contrast, volumetric chest CT images from adults; the technological comparison describes adults older than 22 and input images originating within the hospital network associated with the ILD center.
- Who uses it? Intended users: Clinicians qualified in the care of lung disease, specifically ILD-center specialists experienced in evaluating chest CTs for ILD
- What does the software produce? Output: Identification of positive findings suggestive of radiological UIP and a summary report with a clinical-guideline reference on a dedicated worklist; the device does not alter the original image and does not communicate images to patients.
- What is its most important limitation? Key limitation: The output is informational and not a diagnostic device. Notified clinicians must view the full image series, use additional patient information and professional judgment, and make final clinical determinations. The intended context is adult non-contrast chest CT from the associated hospital network; exact commercial interface details are not established.
Clinical takeaway
Clinical role: Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not diagnosis.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: standalone performance assessment of 804 individual patient images with radiological UIP+ prevalence of 193/804 (24.0%); five independent U.S.-board-certified radiologists with at least five years of ILD chest-CT experience established ground truth. Primary endpoints were AUC ROC 96.6% (95.4%-97.7%) and PPV 77.9% (73.3%-82.8%); secondary specificity was 91.5% (89.2%-93.7%) and sensitivity 90.2% (86.2%-94.3%).
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 referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not diagnosis.
- Intended users
- Clinicians qualified in the care of lung disease, specifically ILD-center specialists experienced in evaluating chest CTs for ILD
- Care setting and population
- Interstitial-lung-disease center referral workflow using chest CT images from the associated hospital network
- Workflow role
- Passive triage/referral notification on a dedicated worklist separate from and parallel to standard-of-care image interpretation
- Required input
- Non-contrast, volumetric chest CT images from adults; the technological comparison describes adults older than 22 and input images originating within the hospital network associated with the ILD center.
- Output and human action
- Identification of positive findings suggestive of radiological UIP and a summary report with a clinical-guideline reference on a dedicated worklist; the device does not alter the original image and does not communicate images to patients.
- Limitations
- The output is informational and not a diagnostic device. Notified clinicians must view the full image series, use additional patient information and professional judgment, and make final clinical determinations. The intended context is adult non-contrast chest CT from the associated hospital network; exact commercial interface details are not established.
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
- Dedicated IQ-UIP worklist application separate from standard-of-care workflow, with input images originating within the hospital network associated with the ILD center; the exact subject packet does not establish a specific PACS/RIS/EHR interface or DICOM transport detail.
- Deployment and data flow
- On-premise
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 IQ-UIP; 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 packet: standalone performance assessment of 804 individual patient images with radiological UIP+ prevalence of 193/804 (24.0%); five independent U.S.-board-certified radiologists with at least five years of ILD chest-CT experience established ground truth. Primary endpoints were AUC ROC 96.6% (95.4%-97.7%) and PPV 77.9% (73.3%-82.8%); secondary specificity was 91.5% (89.2%-93.7%) and sensitivity 90.2% (86.2%-94.3%).
- Reported sensitivity
- 90.2% (95% CI: 86.2%, 94.3%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 91.5% (95% CI: 89.2%, 93.7%)
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.
IQ-UIP regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K242467
- Samplen=804
- IndependenceIndependence not established
K242467
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 K242467 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 K242467. 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 K242467 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 K242467: IQ-UIP
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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IQ-UIP model card (K242467)
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 K242467
Scope: postmarketSafety
Research history
-
K242467 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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