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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 K163157
Device Name SmartGrid
Applicant
Carestream Health
150 Verona Street
ROCHESTER,  NY  14468
Applicant Contact Diane Koetter
Correspondent
Carestream Health
150 Verona Street
ROCHESTER,  NY  14468
Correspondent Contact Diane Koetter
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/10/2016
Decision Date 03/21/2017
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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