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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K033066
Device Name XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
Applicant
Xitec Holdings, LLC
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DANIEL J DILLON
Correspondent
Xitec Holdings, LLC
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DANIEL J DILLON
Regulation Number892.1650
Classification Product Code
OXO  
Date Received09/29/2003
Decision Date 11/12/2003
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
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