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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 K213302
Device Name exoplan
exocad GmbH
37, Julius-Reiber-Str.
Darmstadt,  DE 64293
Applicant Contact Tobias Turba
exocad GmbH
37, Julius-Reiber-Str.
Darmstadt,  DE 64293
Correspondent Contact Tobias Turba
Regulation Number892.2050
Classification Product Code
Date Received10/04/2021
Decision Date 05/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls