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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 K200750
Device Name Neuro.Al Algorithm
Applicant
TeraRecon, Inc.
4309 Emperor Blvd., Suite 310
Durham,  NC  27703
Applicant Contact Megha Jain
Correspondent
TeraRecon, Inc.
4309 Emperor Blvd., Suite 310
Durham,  NC  27703
Correspondent Contact Patrick Willhite
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/23/2020
Decision Date 11/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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