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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 K240020
Device Name Ziehm Vision FD
Applicant
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Applicant Contact Tsvetelina Milanova
Correspondent
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Correspondent Contact Tsvetelina Milanova
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received01/02/2024
Decision Date 01/30/2024
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
Recalls CDRH Recalls
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