Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
AI4CMR v1.0
AI4MedImaging Medical Solutions S.A.
Authorized purpose: Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone clinical decision-making.
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: Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone clinical decision-making.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone clinical decision-making.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Heart, including left and right ventricles, myocardium, and cardiac chambers Input: Cardiac MR images from 1.5T and 3T scanners, including multi-slice MR data received through a DICOM viewer that provides the user interface and connection to a PACS or scanner.
- Who uses it? Intended users: The user incorporating AI4CMR into a DICOM application of choice
- What does the software produce? Output: Anatomical and tissue segmentation; LV/RV stroke volume, cardiac output, ejection fraction, end-diastolic volume, end-systolic volume, and myocardial mass; derived indices when required patient height and weight are present in DICOM; and report or DICOM Secondary Capture outputs.
- What is its most important limitation? Key limitation: Results are not for standalone clinical decision-making, and the user is responsible for implementing the DICOM viewer user interface. Indices derived from height and weight are available only when those values are included in the DICOM data. The FDA evidence uses small bench and retrospective MRMC datasets across specified 1.5T/3T scanners and establishes measurement agreement and segmentation endpoints rather than autonomous diagnosis.
Clinical takeaway
Clinical role: Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone clinical decision-making.
Evidence takeaway
Evidence from the reviewed source record: FDA bench testing used 15 CMR cases annotated by seven independent expert readers across 1.5T and 3T Siemens, GE, and Philips scanners; average myocardium segmentation Dice similarity coefficient was 0.72. Reported measurement agreement included LV EF bias 3.87 (SD 5.74), LV ICC 0.96; RV EF bias 7.80 (7.32), RV ICC 0.81; LV EDV bias 8.66 (17.28), LV ICC 0.99; RV EDV bias 8.36 (15.59), RV ICC 0.96; LV ESV bias -2.90 (17.52), LV ICC 0.99; RV ESV bias -9.08 (13.83), RV ICC 0.95; and LV myocardial-mass bias 2.45 (18.04), ICC 0.96. The retrospective MRMC clinical performance assessment used 146 CMR cases and two expert readers to evaluate agreement with manual segmentation and measurements; the reviewed text does not provide a single diagnostic sensitivity or specificity result.
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
- Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone clinical decision-making.
- Intended users
- The user incorporating AI4CMR into a DICOM application of choice
- Care setting and population
- Healthcare setting using a third-party DICOM viewer connected to a PACS or scanner; the FDA packet does not specify a more specific facility type.
- Workflow role
- Post-processing cardiac MR segmentation and quantification through a plug-in to a third-party DICOM viewer, with results made available to the user for review and reporting.
- Required input
- Cardiac MR images from 1.5T and 3T scanners, including multi-slice MR data received through a DICOM viewer that provides the user interface and connection to a PACS or scanner.
- Output and human action
- Anatomical and tissue segmentation; LV/RV stroke volume, cardiac output, ejection fraction, end-diastolic volume, end-systolic volume, and myocardial mass; derived indices when required patient height and weight are present in DICOM; and report or DICOM Secondary Capture outputs.
- Limitations
- Results are not for standalone clinical decision-making, and the user is responsible for implementing the DICOM viewer user interface. Indices derived from height and weight are available only when those values are included in the DICOM data. The FDA evidence uses small bench and retrospective MRMC datasets across specified 1.5T/3T scanners and establishes measurement agreement and segmentation endpoints rather than autonomous diagnosis.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- AI4CMR is described as a cloud-hosted service implemented as a plug-in to any third-party DICOM viewer; the viewer serves as the user interface and the interface to a PACS or scanner. DICOM input and report/DICOM Secondary Capture output are described, but specific PACS, RIS, EHR, interface versions, and current local compatibility are not established.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
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 AI4CMR v1.0; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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 bench testing used 15 CMR cases annotated by seven independent expert readers across 1.5T and 3T Siemens, GE, and Philips scanners; average myocardium segmentation Dice similarity coefficient was 0.72. Reported measurement agreement included LV EF bias 3.87 (SD 5.74), LV ICC 0.96; RV EF bias 7.80 (7.32), RV ICC 0.81; LV EDV bias 8.66 (17.28), LV ICC 0.99; RV EDV bias 8.36 (15.59), RV ICC 0.96; LV ESV bias -2.90 (17.52), LV ICC 0.99; RV ESV bias -9.08 (13.83), RV ICC 0.95; and LV myocardial-mass bias 2.45 (18.04), ICC 0.96. The retrospective MRMC clinical performance assessment used 146 CMR cases and two expert readers to evaluate agreement with manual segmentation and measurements; the reviewed text does not provide a single diagnostic sensitivity or specificity result.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
AI4CMR v1.0 regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K220624
- Samplen=15
- IndependenceIndependence not established
K220624
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K220624 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K220624. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K220624 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
22Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, 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
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FDA K220624: AI4CMR v1.0
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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AI4CMR v1.0 model card (K220624)
Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K220624
Scope: postmarketSafety
Research history
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K220624 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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