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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 K153318
Device Name Philips Eleva Workspot with SkyFlow
Applicant
Philips Medical Systems Dmc GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Applicant Contact MING XIAO
Correspondent
Philips Medical Systems Dmc GmbH
Roentgenstrasse 24-26
Hamburg,  DE 22335
Correspondent Contact MING XIAO
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received11/18/2015
Decision Date 12/22/2015
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
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