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FDA-cleared K261519

Sonio Suspect

Sonio

Authorized purpose: Concurrent physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2026-06-04
FDA-cleared K252433

Sonio Detect (v3)

Sonio

Authorized purpose: Sonio Detect v3 analyzes fetal ultrasound images and clips to detect views and anatomical structures and to check labeled image-quality characteristics during acquisition or interpretation.

Modality
Ultrasound
Anatomy
Fetal anatomy
Decision
2026-03-16
FDA-cleared K243614

Sonio Suspect

Sonio

Authorized purpose: Concurrent or post-exam fetal ultrasound aid that identifies and characterizes eight abnormal findings for interpreting-physician review; not the sole basis for management.

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2025-02-21
FDA-cleared K240406

Sonio Detect

Sonio

Authorized purpose: Concurrent aid during acquisition and interpretation of fetal ultrasound examinations across gestational ages 11-37 weeks to detect supported views and structures and verify view quality criteria and characteristics.

Modality
Ultrasound
Anatomy
Fetus/obstetric anatomy, including fetal brain, heart/thorax, abdomen, placenta, and genitalia
Decision
2024-04-26
FDA-cleared K230365

Sonio Detect

Sonio

Authorized purpose: Analyze fetal ultrasound images and clips to automatically detect views, detect anatomical structures within views, and verify view-quality criteria as a concurrent reading aid during acquisition and interpretation.

Modality
Ultrasound
Anatomy
Fetus and fetal anatomy
Decision
2023-07-25