AI4CMR v2.0

Evidence summary

FDA describes a 167-case/61-subject flow-model dataset. ACR separately reports a 296-case, one-site regulatory summary. These cohorts and reported Dice contexts were not reconciled; they are not pooled or converted into a single performance claim.

Conflicting sources Exact FDA submission Checked 2026-09-05

FDA detailed flow testing and ACR regulatory summary report different cohort descriptions; retain both sources pending reconciliation.

• Source
• Source

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

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.

• Verify deployment and data flow: Cloud plug-in architecture does not establish data region, retention or local implementation configuration.
• Verify security and privacy controls: No scoped dated cloud security evidence reviewed.
• Verify training: CMR reader training and flow-editing requirements require vendor confirmation.
• Verify reimbursement and coding relevance: No applicable payer policy reviewed.
• Verify local validation and lifecycle monitoring: Version-update validation and flow-edit monitoring require confirmation.
• Verify recalls and postmarket safety signals: 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.

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

• K252084 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• AI4CMR v2.0 model card (K252084) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• AI4CMR v2.0: K252084 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• AI4CMR integration and interoperability Ai4medimaging · 2026-09-05