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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, x-ray, fluorographic, cine or spot
510(k) Number K920793
Device Name PHILIPS DSI SYSTEM RELEASE 3.2
Original Applicant
PHILIPS MEDICAL SYSTEMS, INC.
veenpluis 4-6
p.o. box 10000
5680 da best,  NL
Original Contact william g mcmahon
Regulation Number892.1620
Classification Product Code
IZJ  
Date Received02/21/1992
Decision Date 07/17/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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