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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K261519
Device Name Sonio Suspect
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 Number892.2060
Classification Product Code
POK  
Subsequent Product Code
QIH  
Date Received05/07/2026
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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