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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 K252503
Device Name Intelligent NR
Applicant
Canon, Inc.
30-2, Shimomaruko 3-Chome
Ohta-Ku
Tokyo,  JP 146-8501
Applicant Contact Masahiro Abe
Correspondent
Ken Block Consulting, LLC
3400 N Central Expy., Suite 100-265
Richardson,  TX  75080
Correspondent Contact Saori Sawaki
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
MQB  
Date Received08/08/2025
Decision Date 04/30/2026
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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