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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K210831
Device Name OnQ Neuro
Applicant
CorTechs Labs, Inc
5060 Shoreham Place, Suite 240
San Diego,  CA  92122
Applicant Contact Kora Marinkovic
Correspondent
CorTechs Labs, Inc
5060 Shoreham Place, Suite 240
San Diego,  CA  92122
Correspondent Contact Kora Marinkovic
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/19/2021
Decision Date 11/19/2021
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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