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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 K260234
Device Name MSK Go
Applicant
Smart Alfa Teknoloji San. Ve Tic. A.S.
Universiteler Mah. Ihsan Dogramaci Blv. No:17-1 #109
Cankaya
Ankara,  TR 06800
Applicant Contact Utku Kaya
Correspondent
Smart Alfa Teknoloji San. Ve Tic. A.S.
Universiteler Mah. Ihsan Dogramaci Blv. No:17-1 #109
Cankaya
Ankara,  TR 06800
Correspondent Contact Utku Kaya
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/26/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Clinical Trials NCT07336407
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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