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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 K142740
Device Name Ziehm Vision RFD 3D
Applicant
Ziehm Imaging GmbH
Donaustrasse 31
Nuremberg,  DE D-90451
Applicant Contact STEFAN FIEDLER
Correspondent
Ziehm Imaging GmbH
6280 Hazeltine National Dr.
Orlando,  FL  32822
Correspondent Contact RICHARD L WESTRICH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   JAK   OXO  
Date Received09/24/2014
Decision Date 04/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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