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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 K231573
Device Name ThinkQA (Edition 2)
Applicant
DOSIsoft SA
45/47 Avenue Carnot
Cachan,  FR 94230
Applicant Contact Marc Uszynski
Correspondent
DOSIsoft SA
45/47 Avenue Carnot
Cachan,  FR 94230
Correspondent Contact Ahmad Khalil
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/31/2023
Decision Date 01/18/2024
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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