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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 Drive , Suite 200
Littleton,  CO  80120
Applicant Contact John A Kelley
Correspondent
CereMetrix Corp
991 Southpark Drive , 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
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