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FDA-cleared K250959

BioticsAI

Bioticsai, Inc.

Authorized purpose: BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating quality-criteria verification on DICOM images and frames; it is a concurrent reading aid for the labeled GE ultrasound and prenatal population.

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2025-12-22