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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 K210415
Device Name QSM software, QSMetric
Applicant
Medimagemetric LLC
171 Floral Ave
Johnson City,  NY  13790
Applicant Contact Yi Wang
Correspondent
Medimagemetric LLC
455 Main Street, #7H
New York,  NY  10044
Correspondent Contact Yi Wang
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/11/2021
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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