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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prognostic Assessment Software Of Mild Cognitive Impairment
510(k) Number K261805
Device Name NEXT-Cue
Applicant
Neuroxt, Inc.
#917-919, 48, Achasan-Ro 17-Gil, Seongdong-Gu
Seoul,  KR 04799
Applicant Contact Sunyoung Kim
Correspondent
Neuroxt, Inc.
#917-919, 48, Achasan-Ro 17-Gil, Seongdong-Gu
Seoul,  KR 04799
Correspondent Contact Sunyoung Kim
Classification Product Code
QWT  
Date Received06/01/2026
Decision Date 10/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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