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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Management Software For Planning Of Otologic And Neurotologic Procedures
510(k) Number K203486
Device Name Otoplan
Applicant
Cascination AG
Steigerhubelstrasse 3
Bern,  CH CH-3008
Applicant Contact Jean-Francois Clemence
Correspondent
Cascination AG
Steigerhubelstrasse 3
Bern,  CH CH-3008
Correspondent Contact Jean-Francois Clemence
Regulation Number892.2050
Classification Product Code
QQE  
Date Received11/27/2020
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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