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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K173145
Device Name CereMetrix Silver
Applicant
Ceremetrix Corp
991 Southpark Dr. , Suite 200
Littleton,  CO  80120
Applicant Contact John A Kelley
Correspondent
Ceremetrix Corp
991 Southpark Dr. , Suite 200
Littleton,  CO  80120
Correspondent Contact John A Kelley
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/29/2017
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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