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B-Right Screen Fetal Heart

BRIGHTHEART · Model V1.0.0 · UDI-DI 03760415600000

POK Prescription
10
510(k) clearances
1
Adverse events
0
Recalls
16
Facilities

Description

Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.