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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 K252496
Device Name Neurophet AQUA AD Plus
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 Received08/08/2025
Decision Date 01/29/2026
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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