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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 K053043
Device Name ENCOMPASS SOFTWARE PACKAGE
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin,  CA  92781 -2068
Original Contact paul biggins
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/28/2005
Decision Date 11/18/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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