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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K230854
Device Name SwiftMR
Applicant
AIRS Medical Inc.
13-14F, Keungil Tower, 223, Teheran-ro
Gangnam-gu
Seoul,  KR 06142
Applicant Contact Jihyeon Seo
Correspondent
AIRS Medical Inc.
13-14F, Keungil Tower, 223, Teheran-ro
Gangnam-gu
Seoul,  KR 06142
Correspondent Contact Jihyeon Seo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/28/2023
Decision Date 10/27/2023
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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