Obstetrics_gynecology
Sonio Detect
Sonio
FDACE
FDA-cleared AI medical device
Real-time AI that checks the completeness and quality of obstetric ultrasound image acquisition and flags anomalies during fetal screening exams.
FDA Submission Metadata
- Submission number
- K240406
- Decision date
- April 2024
- FDA panel
- Radiology
- Product code
- IYN
- Clinical task (npj)
- acquisition guidance|quantification/feature localization
- Data modality (npj)
- Images
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA
US FDA 510k
CE
EU CE MDR