cvi42 Software Application

Evidence summary

FDA verification and validation covered non-ML outputs and machine-learning modules. Validation used 235 anonymized patient images with component-specific counts: 70 coronary, 102 calcium, 63 SAX function, 63 each for 2-, 3-, and 4-chamber LAX function, and 252 function-classification samples. Reported ranges were 97%-100% series classification, 7%-10% SAX and 5%-9% LAX volumetric MAE, 86%-99% calcium classification, 82%-94% coronary centerline performance, and 98%-100% coronary-mask performance. Cardiac CT segmentation reported LV MAE below 10%, Dice above 86%, Hausdorff distance below 9.5 mm, and EF bias 1.3% (95% CI -12 to 14); RV MAE below 18%, Dice above 85%, Hausdorff distance below 18 mm, and EF bias -5.5% (95% CI -15 to 4.4); LV-myocardium MAE below 17%, Dice above 82%, and Hausdorff distance below 15 mm.

• FDA source
• Exact FDA submission
• Checked 2026-09-08

• Source

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

Postmarket safety review

The exact-identifier FDA recall query returned no native recall record for K242781. 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 2026-09-08

• Source

• 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 K242781 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.

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 0 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