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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 K252670
Device Name Alzevita
Applicant
TOPIA MEDTECH LIMITED
14 Havelock Place (Ms)
Harrow,  GB HA11LJ
Applicant Contact Akshay Sojitra
Correspondent
TOPIA MEDTECH LIMITED
14 Havelock Place (Ms)
Harrow,  GB HA11LJ
Correspondent Contact Akshay Sojitra
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/25/2025
Decision Date 12/19/2025
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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