Radiology AI Directory

FDA-cleared profile

PRAEVAorta®2

Nurea

PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images; results require clinical assessment and physician validation when obtained by a non-physician.

Cardiac imagingQuantification and segmentation
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
PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images; results require clinical assessment and physician validation when obtained by a non-physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Clinical specialists, physicians, and other licensed practitioners; non-physician results must be validated by the responsible physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adults in healthcare institutions, including clinics, hospitals, residential care, and long-term care services.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Measurement or quantification
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
DICOM CT images containing blood vessels; the assessment included contrast and noncontrast scans, preoperative and postoperative cases, and aortic stent grafts.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Vascular reconstruction and aneurysm/thrombus segmentation; diameters, volumes, angles, and distances between anatomical points; PDF, JSON, DICOM SC reports, and DICOM GSPS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Adult use. Results are not a standalone basis for clinical decisions and do not replace clinical assessment. Results obtained by non-physicians require physician validation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K243859
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Catalog category retained; exact scope includes aorta and iliac vessels in thoraco-abdomino-pelvic CT.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-08-29
  • 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
Server software accessed through APIs, with a web client, gateway/PACS client, integrating solution, or marketplace; PDF, JSON, DICOM SC, and DICOM GSPS outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Specific PACS versions and supported transactions require local confirmation.

Deployment and data flow
Hybrid
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

The FDA summary explicitly permits cloud-based or on-premises installation; it does not establish a current hosting region or contract.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

FDA functional data-security testing and general vendor language do not establish a current scoped attestation, hosting region, retention policy, or access-control configuration.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Training of reference readers in the FDA study is not a customer onboarding commitment. Current user training and support terms remain unverified.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Local acceptance, output correction, update control, and incident escalation require vendor and site documentation.

API deployment and reports

Cloud or on-premises server deployment through APIs, with PDF, JSON, DICOM SC, and DICOM GSPS results.

exact submission · checked 2026-09-05
Source

Current vendor workflow

Nurea describes automatic arterial reconstruction integrated with PACS, workstations, and imaging software, including lumen/thrombus differentiation and longitudinal follow-up.

product family · checked 2026-09-05

Current product-family description. Local compatibility and any features beyond the FDA indications require separate confirmation.

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 technical assessment used 159 independent adult CT cases from the United States, France, and Canada, with four vascular surgeons providing manual measurement reference. Maximum orthogonal aortic-diameter mean absolute error was 2.04 mm (95% CI 1.75-2.34); 96.9% of values were within 5 mm. The latter is measurement agreement, not disease-detection accuracy.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

Reviewed testing reports diameter error and agreement; no disease-detection sensitivity with a defined endpoint was established.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

Reviewed testing reports diameter error and agreement; no disease-detection specificity with a defined endpoint was established.

Maximum orthogonal aortic-diameter mean absolute error

2.04 mm

  • EndpointAgreement with four vascular surgeons' manual reference measurements; acceptance required at least 96% within 5 mm and correlation above 0.90.
  • Population159 adult CT cases: 81 US, 40 France, 38 Canada; 95 preoperative and 64 postoperative, 62 with aortic stent grafts; contrast and noncontrast scans.
  • Tested versionPRAEVAorta 2 submitted in K243859; build not stated in reviewed text
Source

PRAEVAorta 2 FDA technical measurement assessment

  • DesignStandalone technical comparison against four vascular surgeons' manual measurements
  • PopulationAdult contrast and noncontrast CT before or after vascular intervention
  • Scopeexact submission
  • Tested versionPRAEVAorta 2 in K243859; build not reported
  • Samplen=159
  • IndependenceIndependence not established

K243859

Cases were separate from AI training. FDA regulatory testing, not an independent publication.

Source

Validation Study Comparing Artificial Intelligence for Fully Automatic Aortic Aneurysms Segmentation and Diameter Measurements on Contrast and Noncontrast Enhanced Computed Tomography

  • DesignSingle-center retrospective comparative study
  • Population120 CT scans, equally divided between CTA and noncontrast CT, in aneurysm-repair and control cases; two vascular surgeons provided semiautomatic comparison measurements.
  • Scopeproduct family
  • Tested versionPRAEVAorta2; exact build and K243859 equivalence not established
  • Samplen=120
  • Sites1
  • IndependenceIndependence not established

PMID:40480487 · DOI:10.1016/j.avsg.2025.05.045

Abstract and affiliations reviewed; a Nurea-affiliated author is listed. Numeric results are not transferred to K243859. This is scan count, not unique-patient count.

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 2026-09-05

The reviewed official product page offers a demo without scoped pricing. Licensing, processing volume, client/integration costs, support, and cloud/on-premises terms require quotation; procurement research is incomplete.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer policy was reviewed. No named-product coverage or payment conclusion is made.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-05Last searched
27Fields reviewed
12Source classes checked
2Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads

All stored metadata screened. PMID 40480487 abstract supports a contextual PRAEVAorta2 study, without exact-build linkage. PMID 41321026 concerns carotid-lesion segmentation; exact aortic-product applicability not established and no results promoted. Live registry content identifies NCT05287828 and NCT05920317 as Nurea/PRAEVAorta-family studies; no posted results or exact K243859 build linkage were established, so neither is promoted as exact-submission clinical performance. The current discovery snapshot contains 2 PubMed and 2 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 decision material, vendor product page, literature index, peer reviewed literature, trial registry, fda device recall, 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 510(k) K243859: PRAEVAorta 2

    U.S. Food and Drug Administration - Published 2025-08-29 - Accessed 2026-09-05

    Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceMetrics

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PRAEVAorta®2 model card (K243859)

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

    Scope: intendedUsers, careSetting, output, 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. PRAEVAorta 2 decision support software for vascular diseases

    Nurea - Accessed 2026-09-05

    Scope: productFamilyWorkflow, implementationCapabilities

  8. Validation Study Comparing Artificial Intelligence for Fully Automatic Aortic Aneurysms Segmentation and Diameter Measurements on Contrast and Noncontrast Enhanced Computed Tomography

    Annals of Vascular Surgery; abstract via PubMed - Published 2025-06-04 - Accessed 2026-09-05

    Scope: contextualEvidenceStudy

Research history

  1. K243859 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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