Radiology AI Directory

FDA-cleared profile

AI4CMR v2.0

Ai4medimaging Medical Solutions S.A.

Authorized purpose: Cardiac MRI ventricular function and 2D phase-contrast flow quantification

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.

Product overview

Start with the essentials

Authorized purpose: Cardiac MRI ventricular function and 2D phase-contrast flow quantification

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Cardiac MRI ventricular function and 2D phase-contrast flow quantification

Evidence takeaway

Evidence from the reviewed source record: FDA flow-model validation used 167 cases from 61 subjects. The packet contains multiple Dice contexts, so no single Dice result is presented.

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
Cardiac MRI ventricular function and 2D phase-contrast flow quantification
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Trained medical professionals interpreting cardiac MR
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Segmentation and measurement support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
DICOM 1.5T or 3T cardiac MR cine and two-dimensional phase-contrast flow acquisitions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
LV/RV volumes, ejection fraction, mass and indexed measurements; aortic/pulmonary vessel masks and forward/backward/net flow, regurgitant fraction, maximum velocity and pressure gradient.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
2D flow model is not for patients under 18, 4D flow, extreme congenital distortion or low-SNR data; clinician review/editing is required.
  • 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
K252084
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-02-11
  • 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
Cloud plug-in service implemented through a third-party DICOM viewer interface to PACS/scanner workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Cloud plug-in architecture does not establish data region, retention or local implementation configuration.

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

No scoped dated cloud security evidence reviewed.

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

CMR reader training and flow-editing requirements require vendor confirmation.

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

Version-update validation and flow-edit monitoring require confirmation.

Current interoperability

Vendor describes DICOM, HL7 and FHIR integration options.

product family ยท checked 2026-09-05

Current page does not establish exact v2.0 implementation compatibility.

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 flow-model validation used 167 cases from 61 subjects. The packet contains multiple Dice contexts, so no single Dice result is presented.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Exact FDA flow-model validation is stated without pooling it with the separate ACR regulatory summary or promoting a single Dice result.

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

Segmentation agreement does not establish diagnostic sensitivity.

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

No diagnostic specificity established.

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

AI4CMR v2.0 ACR regulatory performance study summary

  • DesignStandalone performance summary
  • PopulationAdult
  • Scopeexact submission
  • Tested version2
  • Samplen=296
  • Sites1
  • IndependenceIndependence not established

K252084

Preserved baseline ACR study. Exact FDA flow validation is described separately and should not be assumed the same cohort.

Source

K252084 flow-model validation

  • DesignModel validation dataset
  • PopulationCardiac MR flow cases from 61 subjects
  • Scopeexact submission
  • Tested versionAI4CMR v2.0 flow model
  • Samplen=167
  • IndependenceIndependence not established

K252084

Detailed FDA sections contain inconsistent Dice contexts; no numeric score is promoted.

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 advertises a pay-per-exam commercial model; rate and v2.0 contract terms not public in reviewed material.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05
Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer policy reviewed.

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
2026-09-06Last searched
20Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored PubMed and clinical-trial arrays are empty and were screened. 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, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, recall database, 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. K252084 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. AI4CMR v2.0 model card (K252084)

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

    Scope: purpose, modality, 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. AI4CMR v2.0: K252084 decision and 510(k) summary

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

    Scope: identity, clinical, evidence, implementation

  8. AI4CMR integration and interoperability

    Ai4medimaging - Accessed 2026-09-05

    Scope: implementation, economics

Research history

  1. K252084 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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