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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252452
Device Name PeekMed web
Applicant
Peek Health, S.A.
Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas
Braga,  PT 4719-005
Applicant Contact Sara Silva
Correspondent
Peek Health, S.A.
Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas
Braga,  PT 4719-005
Correspondent Contact Sara Silva
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received08/04/2025
Decision Date 11/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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