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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K252433
Device Name Sonio Detect (v3)
Applicant
Sonio
147 Rue D'Aboukir
Paris,  FR 750002
Applicant Contact Florian Akpakpa
Correspondent
Sonio
147 Rue D'Aboukir
Paris,  FR 750002
Correspondent Contact Florian Akpakpa
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received08/01/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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