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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, Fluoroscopic, Image-Intensified
510(k) Number K203428
Device Name Ziehm Vision RFD
Applicant
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Applicant Contact Stefan Fiedler
Correspondent
Ziehm-Orthoscan, Inc.
14555 N 82nd St.
Scottsdale,  AZ  85260
Correspondent Contact Steve Seeman
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Codes
OWB   OXO  
Date Received11/20/2020
Decision Date 03/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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