Radiology AI Directory

FDA-cleared profile

CINA-iPE

Avicenna.AI

Authorized purpose: Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device

Pulmonary embolismQuantification and segmentationAcute 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.

Product overview

Start with the essentials

Authorized purpose: Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device

Evidence takeaway

Evidence from the reviewed source record: Retrospective multicenter, multinational, blinded standalone study of 381 cases: 181 positive and 200 negative, with ground truth by consensus of three US-board-certified expert radiologists. Global sensitivity was 87.8% (95% CI 82.2%-92.2%) and specificity 92.0% (87.3%-95.4%) against an 80% performance goal. Sensitivity by overlapping lesion-location groups was main 96.3%, interlobar 94.5%, lobar 92.9%, and segmental 88.3%. Mean time-to-notification was 1.5 minutes for all cases and 1.5 minutes for 159 true-positive cases

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
Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Hospital networks and trained radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital radiology worklist workflow for adults and transitional adolescents aged 18-21 treated as adults
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Standalone triage application operating in parallel with standard of care; all studies appear in the worklist, flagged series receive notification and passive marking, and the original images remain the basis for review
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM contrast-enhanced CT scans, not dedicated CTPA, including at least part of the lung; intended for adults and transitional adolescents aged 18-21 treated as adults
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Passive worklist icon and active notification for suspected incidental PE, with a compressed grayscale unannotated preview marked not for diagnostic use; results files are transferred for PACS/workstation prioritization and the original image is not altered
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not designed to detect PE in subsegmental arteries; preview images are informational and not diagnostic; results are not for standalone diagnosis and notified clinicians must review the full study using standard of care; the input is CT for another indication rather than a dedicated CTPA protocol
  • 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
K233968
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Lung and pulmonary arterial segments containing incidental pulmonary embolism; subsegmental arteries are out of scope
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-03-13
  • 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
CINA-iPE can run with the CINA Platform cleared under K200855 or another medical image communications device. DICOM services communicate with CT modalities, routers, PACS, and the Worklist Application; exact local interface versions are not established
  • 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.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for CINA-iPE; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท 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
Retrospective multicenter, multinational, blinded standalone study of 381 cases: 181 positive and 200 negative, with ground truth by consensus of three US-board-certified expert radiologists. Global sensitivity was 87.8% (95% CI 82.2%-92.2%) and specificity 92.0% (87.3%-95.4%) against an 80% performance goal. Sensitivity by overlapping lesion-location groups was main 96.3%, interlobar 94.5%, lobar 92.9%, and segmental 88.3%. Mean time-to-notification was 1.5 minutes for all cases and 1.5 minutes for 159 true-positive cases
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
87.8% (95% CI: 82.2%, 92.2%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
92.0% (95% CI: 87.3%, 95.4%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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.

CINA-iPE regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K233968
  • Samplen=381
  • IndependenceIndependence not established

K233968

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 K233968 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 K233968. 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
2026-09-20Last searched
24Fields reviewed
9Source classes checked
2Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 2 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 2 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

  1. FDA K233968: CINA-iPE

    U.S. Food and Drug Administration - Published 2024-03-13 - 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. CINA-iPE model card (K233968)

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

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  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 K233968

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

    Scope: postmarketSafety

Research history

  1. K233968 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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