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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K252937
Device Name ThinkQA 3
Applicant
Dosisoft SA
45/47 Ave. Carnot
Cachan,  FR 94230
Applicant Contact Marc Uszynski
Correspondent
Dosisoft SA
45/47 Ave. Carnot
Cachan,  FR 94230
Correspondent Contact Ahmad Khalil
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received09/15/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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