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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 K210999
Device Name SwiftMR
Applicant
AIRS Medical Inc.
8-9F, CS Tower, 1838, Nambusunhwan-ro, Gwanak-gu
Seoul,  KR 08788
Applicant Contact Jihyeon Seo
Correspondent
AIRS Medical Inc.
8-9F, CS Tower, 1838, Nambusunhwan-ro, Gwanak-gu
Seoul,  KR 08788
Correspondent Contact Jihyeon Seo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/02/2021
Decision Date 10/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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