Fetal EchoScan

Evidence summary

FDA K242342 reports standalone testing on 877 clinically acquired second-trimester fetal ultrasound exams from 11 centers, with 98.8% of exams producing a conclusive output. For any suspicious finding, sensitivity/specificity were 0.977/0.977 when inconclusive outputs were counted negative and 0.987/0.963 when counted positive, with separate per-finding results. A distinct fully crossed MRMC reader study used 200 exams and 14 readers: aided AUC was 0.974 versus unaided 0.825, aided mean sensitivity was 0.935 versus 0.782, and aided mean specificity was 0.970 versus 0.759.

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 K242342. 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 K242342 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

• FDA K242342: Fetal EchoScan U.S. Food and Drug Administration · 2026-09-08
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Fetal EchoScan model card (K242342) 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
• openFDA exact recall query for K242342 U.S. Food and Drug Administration · 2026-09-08