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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223180
Device Name AIRAscore
Applicant
Airamed GmbH
Konrad-Adenauer-Str. 13
Tübingen,  DE 72072
Applicant Contact Maximilian Stalter
Correspondent
Johner Institut GmbH
Niddastr. 91
Frankfurt,  DE 60329
Correspondent Contact Katharina Keutgen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/11/2022
Decision Date 08/25/2023
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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