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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 K260032
Device Name Morph
Applicant
BeauBrain Healthcare, Inc.
2f, 314, Hakdong-Ro, Gangnam-Gu
Seoul,  KR 06098
Applicant Contact Hyojin Kim
Correspondent
LK Consulting Group USA, Inc.
2552 Walnut Ave. Suite 230
Tustin,  CA  92780
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received01/06/2026
Decision Date 05/13/2026
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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