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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 K171194
Device Name AS-10, CXDI-401RF
Applicant
Canon, Inc.
9-1, Imaikami-Cho,Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Shinji Mori
Correspondent
Ken Block Consulting
1201 Richardson Drive, Suite 160
Richardson,  TX  75080
Correspondent Contact Diane Rutherford
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   MQB  
Date Received04/24/2017
Decision Date 05/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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