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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K232045
Device Name MeVis Liver Suite
Applicant
MeVis Medical Solutions AG
Caroline-Herschel-Strasse 1
Bremen,  DE 28359
Applicant Contact Rolf Rzodeczko
Correspondent
MeVis Medical Solutions AG
Caroline-Herschel-Strasse 1
Bremen,  DE 28359
Correspondent Contact Rolf Rzodeczko
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/10/2023
Decision Date 10/27/2023
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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