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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K141736
Device Name PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
Applicant
PHILIPS MEDICAL SYSTEMS DMC GMBH
ROENTGENSTRASSE 24-26
HAMBURG,  DE 22335
Applicant Contact GEROLD SCHWARZ
Correspondent
PHILIPS MEDICAL SYSTEMS DMC GMBH
ROENTGENSTRASSE 24-26
HAMBURG,  DE 22335
Correspondent Contact GEROLD SCHWARZ
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received06/27/2014
Decision Date 07/25/2014
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
Recalls CDRH Recalls
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