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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 K203849
Device Name General Radiography CXDI-CS01
Applicant
CANON INC.
9-1 Imaikami-Cho, Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Akira Hirai
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 Received12/31/2020
Decision Date 01/26/2021
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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