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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, Tomography, Computed
510(k) Number K073346
Device Name ZIEHM VISION 2
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 Number892.1750
Classification Product Code
JAK  
Date Received11/29/2007
Decision Date 03/21/2008
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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