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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 K200887
Device Name AS-10
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 Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   MQB  
Date Received04/02/2020
Decision Date 04/15/2020
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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