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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 K232022
Device Name CAS-One IR
Applicant
Cascination AG
Steigerhubelstrasse 3
Bern,  CH 3008
Applicant Contact Andreas Meschberger
Correspondent
Cascination AG
Steigerhubelstrasse 3
Bern,  CH 3008
Correspondent Contact Andreas Meschberger
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/07/2023
Decision Date 03/13/2024
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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