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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 East Campbell Road, 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
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