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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 K220349
Device Name TeraRecon Neuro
Applicant
TeraRecon, Inc
4309 Emperor Blvd.
Durham,  NC  27703
Applicant Contact Michael Sosebee
Correspondent
TeraRecon, Inc
4309 Emperor Blvd.
Durham,  NC  27703
Correspondent Contact Michael Sosebee
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/07/2022
Decision Date 08/12/2022
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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