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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 K251483
Device Name SwiftSight-Brain
Applicant
Airs Medical, Inc.
13-14f, Keungil Tower, 223, Teheran-Ro
Gangnam-Gu
Seoul,  KR 06142
Applicant Contact Lee HaeRi
Correspondent
Airs Medical, Inc.
13-14f, Keungil Tower, 223, Teheran-Ro
Gangnam-Gu
Seoul,  KR 06142
Correspondent Contact Lee HaeRi
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/14/2025
Decision Date 09/23/2025
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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