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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 K252563
Device Name Neurophet SCALE PET
Applicant
Neurophet., Inc.
12f, 124, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06234
Applicant Contact Jin Woo Jeong
Correspondent
Neurophet., Inc.
12f, 124, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06234
Correspondent Contact Jin Woo Jeong
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received08/14/2025
Decision Date 05/15/2026
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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