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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
Recalls CDRH Recalls
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