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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
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