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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 K253835
Device Name Affinity
Applicant
Hermes Medical Solutions AB
Strandbergsgatan 16
Stockholm,  SE 11251
Applicant Contact Hanne Grinaker
Correspondent
Hermes Medical Solutions AB
Strandbergsgatan 16
Stockholm,  SE 11251
Correspondent Contact Hanne Grinaker
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Codes
KPS   LLZ  
Date Received12/01/2025
Decision Date 07/31/2026
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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