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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K232298
Device Name DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
Applicant
Canon, Inc.
9-1 Imaikami-Cho Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Shigeo Watanabe
Correspondent
Ken Block Consulting, LLC
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Saori Sawaki
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
MQB  
Date Received08/01/2023
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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