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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 K212269
Device Name Intelligent NR
Applicant
Canon, Inc.
9-1 Imaikami-Cho Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Akira Hirai
Correspondent
Ken Block Consulting
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Gregory Woodard
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/20/2021
Decision Date 09/17/2021
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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