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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 K162909
Device Name CSX-30 Flat Panel Detector
Applicant
Canon, Inc. – Medical Equipment Group
9-1, Imaikami-cho, Nakahara-ku
Kawasaki,  JP 211-8501
Applicant Contact Shinji Mori
Correspondent
Ken Block Consulting
1201 Richardson Drive
Richardson,  TX  75080
Correspondent Contact Diane Rutherford
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
JAA  
Date Received10/17/2016
Decision Date 01/27/2017
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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