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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K223261
Device Name Open Rib
Applicant
Canon Medical Informatics, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343
Applicant Contact Vincent Swenson
Correspondent
Canon Medical Informatics, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343
Correspondent Contact Dr. Jay Vaishnav
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/24/2022
Decision Date 07/13/2023
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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