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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K953164
Device Name ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin,  CA  92781 -2068
Original Contact mark stauffer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/07/1995
Decision Date 08/09/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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