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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 K190368
Device Name Enhanced Feature Software Pack CXDI Series
Applicant
Canon, Inc.
30-2 Shimomaruko, 3-Chrome, Ohta-Ku
Tokyo,  JP 146-8501
Applicant Contact Yamazaki Tatsuya
Correspondent
Ken Block Consulting
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Katie Reneson
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/15/2019
Decision Date 03/13/2019
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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