K252433
- 510(k) number
- K252433
- Device name
- Sonio Detect (v3)
- Applicant
- Sonio FR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-03-16
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252433.pdf
Official FDA record: K252433
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.