FDA-cleared K261519
Sonio Suspect
Sonio
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
Vendor
Sonio
5 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K252433
Sonio Detect (v3)
Sonio
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...
- Modality
- Ultrasound
- Anatomy
- Fetal anatomy
- Decision
- 2026-03-16
FDA-cleared K243614
Sonio Suspect
Sonio
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
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...
- 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
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...
- Modality
- Ultrasound
- Anatomy
- Fetus and fetal anatomy
- Decision
- 2023-07-25