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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 K182973
Device Name DigitalDiagnost C90
Applicant
Philips Medical Systems DMC GmbH
Roentgenstrasse 24
Hamburg,  DE 22335
Applicant Contact Ming Xiao
Correspondent
Philips Medical Systems DMC GmbH
Roentgenstrasse 24
Hamburg,  DE 22335
Correspondent Contact Ming Xiao
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Codes
KPR   LLZ  
Date Received10/26/2018
Decision Date 01/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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