Radiology AI Directory

FDA-cleared profile

Radify Triage

Envisionit DeepAI Ltd

Passively triage adult frontal chest X-rays for suspected pleural effusion and/or pneumothorax by providing case-level PACS worklist output; not a standalone clinical-decision tool or a rule-out result.

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
Passively triage adult frontal chest X-rays for suspected pleural effusion and/or pneumothorax by providing case-level PACS worklist output; not a standalone clinical-decision tool or a rule-out result.
  • 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-radiograph worklist workflow; FDA testing included hospitals and private clinics, but the indication does not restrict a facility type.
  • 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, direct attention to a specific image portion, alter order, remove cases, or flag a condition as absent.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Frontal AP or PA adult chest X-ray images in DICOM format received through PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Case-level passive output in PACS/workstation that flags images suspicious for pleural effusion and/or pneumothorax and generates a secondary capture; unflagged cases remain in the routine reading worklist.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Targets only suspected pleural effusion and pneumothorax on adult frontal AP/PA chest radiographs. It is passive prioritization, not a proactive alert, does not rule out a condition, does not mark a specific image location, and must not be used alone for clinical decision-making. The FDA packet reports different training-set geographic percentages in its device-description and testing sections, so those percentages should not be normalized without clarification.
  • 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
K231871
  • 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
2024-01-17
  • 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 frontal chest radiographs are received through PACS and suspected cases are passively flagged in the PACS/worklist, with secondary-capture output; the FDA comparison references PACS/RIS/EPR destinations but does not establish a specific interface, version, or deployment model.
  • 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

Result destination

PACS and workstation are explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Radify Triage; 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 K231871 reports retrospective standalone testing using 1,229 US scans, including 270 pneumothorax and 392 pleural-effusion cases, with three board-certified ABR radiologists establishing ground truth across a hospital and private clinics. Pneumothorax performance was AUC 97.43 (95% CI 97.12-97.74), sensitivity 94.81% (93.90%-95.73%), and specificity 97.91% (97.00%-98.83%). Pleural-effusion performance was AUC 97.61 (97.36-97.86), sensitivity 94.39% (93.26%-95.51%), and specificity 96.42% (95.29%-98.00%); mean analysis-to-worklist time was 3 seconds.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Pneumothorax: 94.81%; pleural effusion: 94.39%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Condition-specific FDA endpoints are retained separately; the 97.43% value is pneumothorax AUC, not accuracy.

Reported specificity
Pneumothorax: 97.91%; pleural effusion: 96.42%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Condition-specific FDA endpoints are retained separately; the 97.43% value is pneumothorax AUC, not accuracy.

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

Radify® Triage- Pneumothorax regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K231871
  • Samplen=1229
  • Sites3
  • IndependenceIndependence not established

K231871

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 K231871 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 K231871. 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 K231871: Radify Triage

    U.S. Food and Drug Administration - Published 2024-01-17 - 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. Radify® Triage- Pneumothorax model card (K231871)

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

    Scope: intendedUsers, 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 K231871

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

    Scope: postmarketSafety

Research history

  1. K231871 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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