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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 K061203
Device Name ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
Applicant
ZIEHM IMAGING, INC.
4181 LATHAM ST.
RIVERSIDE,  CA  92501
Applicant Contact RICHARD WESTRICH
Correspondent
ZIEHM IMAGING, INC.
4181 LATHAM ST.
RIVERSIDE,  CA  92501
Correspondent Contact RICHARD WESTRICH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received05/01/2006
Decision Date 06/19/2006
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
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