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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 K253775
Device Name SwiftMR
Applicant
Airs Medical, Inc.
13-14f, Keungil Tower, 223, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06142
Applicant Contact Markus Cho
Correspondent
Airs Medical, Inc.
13-14f, Keungil Tower, 223, Teheran-Ro, Gangnam-Gu
Seoul,  KR 06142
Correspondent Contact Markus Cho
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/26/2025
Decision Date 03/26/2026
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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