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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K231692
Device Name Ziehm Vision RFD
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Applicant Contact Stefan Fiedler
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Correspondent Contact Stefan Fiedler
Regulation Number892.1650
Classification Product Code
Subsequent Product Codes
Date Received06/09/2023
Decision Date 11/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No