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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 K240620
Device Name Cube Navigator
Applicant
Medical Templates AG
Brunnenwiese 10
Egg,  CH 8132
Applicant Contact Joscha Hüttel
Correspondent
BeanStock Consulting
8885 Rio San Diego Dr. #237
San Diego,  CA  92108
Correspondent Contact Shawnnah Monterrey
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/05/2024
Decision Date 03/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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