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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 K223659
Device Name Jazz
Applicant
Ai Medical AG
Goldhaldenstr 22a
Zollikon,  CH 8702
Applicant Contact Christian Federau
Correspondent
Ai Medical AG
Goldhaldenstr 22a
Zollikon,  CH 8702
Correspondent Contact Christian Federau
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/06/2022
Decision Date 09/22/2023
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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