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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 K222687
Device Name Digital Radiography CXDI-Elite, Digital Radiography E1
Applicant
Canon, Inc.
9-1 Imaikami-Cho, Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Mr. Akira Hirai
Correspondent
Ken Block Consulting, LLC
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Ms. Saori Sawaki
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/06/2022
Decision Date 09/29/2022
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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