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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K261612
Device Name SwiftSight-BodyComposition
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 Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
QIH  
Date Received05/15/2026
Decision Date 10/01/2026
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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