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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K193287
Device Name CorInsights MRI
Applicant
ADM Diagnostics, Inc.
555 Skokie Boulevard, Suite 500
Northbrook,  IL  60062
Applicant Contact Dawn C. Mathews
Correspondent
Kinetic Compliance Solutions, LLC
PO Box 2134
Milwaukee,  WI  53201
Correspondent Contact Robin Martin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/27/2019
Decision Date 11/20/2020
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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