Radiology AI Directory

FDA-cleared profile

CINA CHEST

Avicenna.AI

Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital networks and trained radiologists with workflow prioritization in parallel with standard-of-care interpretation.

Pulmonary embolismDetection and CADeAcute 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
Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital networks and trained radiologists with workflow prioritization in parallel with standard-of-care interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and trained radiologists; notified clinicians review full images under standard of care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Hospital radiology workflow for triage and prioritization of chest and thoraco-abdominal CTA studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel triage and notification support; it does not alter the original image or provide a diagnostic result beyond notification, and clinicians remain responsible for full-image review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Chest CTA for suspected PE and chest or thoraco-abdominal CTA for suspected AD, received as DICOM images through the CINA Platform or a compatible medical-image communications device.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Worklist pop-up and passive icon notifications identifying suspected PE or AD, with patient name, accession number, finding type, and a compressed preview labeled not for diagnostic use; output files can be transferred to PACS or a workstation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Notifications and compressed previews are informational and not for diagnosis; the device is not intended as a diagnostic device or to replace standard-of-care full-image interpretation. PE and AD are separate applications and performance endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K210237
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Chest and thoraco-abdominal aorta
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-05-19
  • 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
The packet describes an on-premise Worklist Application, standardized DICOM communication with CT modalities and other DICOM nodes such as routers or PACS, and output to PACS/workstations; exact local interface versions are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

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

exact submission · checked 2026-09-09
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
A retrospective multicenter blinded study included 396 PE cases from 230 U.S. cities/sites as stated in the packet and 298 AD cases from 200, with 190 positive PE and 137 positive AD cases; ground truth used concurrence of several U.S.-board-certified radiologists. PE sensitivity/specificity were 91.1% (95% CI 86.1%-94.7%) and 91.8% (87.1%-95.1%); AD sensitivity/specificity were 96.4% (91.7%-98.8%) and 97.5% (93.8%-99.3%). Overall agreement was 91.4% for PE and 97% for AD, MCC was 0.83 and 0.94, and mean time-to-notification was 63 seconds for PE and 36.5 seconds for AD. These are separate condition-specific sensitivity/specificity, agreement, correlation, and latency endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
PE triage sensitivity: 91.1% (95% CI 86.1%-94.7%); AD triage sensitivity: 96.4% (95% CI 91.7%-98.8%); endpoints are condition-specific.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA packet supports separate PE and AD sensitivity endpoints and does not support one undifferentiated device-level sensitivity.

Reported specificity
PE triage specificity: 91.8% (95% CI 87.1%-95.1%); AD triage specificity: 97.5% (95% CI 93.8%-99.3%); endpoints are condition-specific.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA packet supports separate PE and AD specificity endpoints, retained with their labels and confidence intervals.

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

CINA CHEST-PE 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 K210237
  • Samplen=396
  • Sites230
  • IndependenceIndependence not established

K210237

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 2026-09-09

No public price or quote for the exact K210237 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

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 K210237. 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 2026-09-09

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
2026-09-09Last searched
24Fields reviewed
9Source classes checked
1Awaiting 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 1 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 K210237: CINA CHEST

    U.S. Food and Drug Administration - Published 2021-05-19 - Accessed 2026-09-09

    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 CHEST-PE model card (K210237)

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

    Scope: intendedUsers, output, limitations, 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 K210237

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

    Scope: postmarketSafety

Research history

  1. K210237 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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