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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 K261916
Device Name NeuroQuant PET
Applicant
Cortechs Labs, Inc.
5060 Shoreham Pl.
Suite 240
San Diego,  CA  92122
Applicant Contact Stephen Kosnosky
Correspondent
Cortechs Labs, Inc.
5060 Shoreham Pl.
Suite 240
San Diego,  CA  92122
Correspondent Contact Stephen Kosnosky
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/09/2026
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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