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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 K261273
Device Name Neurophet AQUA
Applicant
Neurophet., Inc.
12f, 124, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06234
Applicant Contact Yerim Lee
Correspondent
Global Medical Standard Consulting Co., Ltd.
#612, De Riverwork Bldg. B
66, Cheongcho-Ro, Deogyang-Gu Goyang-Si
Gyeonggi-Do,  KR 10543
Correspondent Contact Jonghyun Kim
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received04/17/2026
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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