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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 K230175
Device Name Digital Radiography CXDI-CS01
Applicant
Canon, Inc.
9-1 Imaikami-Cho Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Akira Hirai
Correspondent
Canon, Inc.
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Saori Sawaki
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/20/2023
Decision Date 02/15/2023
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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