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FDA-cleared K251368

FETOLY

Diagnoly

Authorized purpose: FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements during the second and third trimesters.

Modality
Ultrasound
Anatomy
Fetal heart and fetal brain
Decision
2025-09-12
FDA-cleared K241380

FETOLY-HEART

Diagnoly

Authorized purpose: Concurrent AI reading aid for routine fetal heart ultrasound examinations in second- and third-trimester pregnancies from 17 to 40 weeks, detecting the five recommended fetal heart views and 52 within-view quality criteria.

Modality
Ultrasound
Anatomy
Obstetric fetal heart
Decision
2024-09-11