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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 K170981
FOIA Releasable 510(k) K170981
Device Name NeuroQuant
Applicant
CorTechs Labs, Inc
4690 Executive Drive, Suite 250
San Diego,  CA  92121
Applicant Contact Kora Marinkovic
Correspondent
CorTechs Labs, Inc
4690 Executive Drive, Suite 250
San Diego,  CA  92121
Correspondent Contact Kora Marinkovic
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2017
Decision Date 09/07/2017
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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