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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 K192632
Device Name DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
Applicant
Canon, Inc.
30-2 Shimomaruko, 3-Chrome, Ohta-Ku
Tokyo,  JP 146-8501
Applicant Contact Yamazaki Tatsuya
Correspondent
Ken Block Consulting
800 East Campbell Road, Suite 202
Richardson,  TX  75081
Correspondent Contact Gregory Woodard
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/23/2019
Decision Date 11/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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