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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 K183621
Device Name EMMA 1.5T MRI System
Applicant
Time Medical Limited
G/F, Bio-Informatics Center
#, 2 Science Park W. Ave.
Shatin, Nt, Hong Kong,  CN
Applicant Contact Nick Tse
Correspondent
Time Medical Limited
G/F, Bio-Informatics Center
#, 2 Science Park W. Ave.
Shatin, Nt, Hong Kong,  CN
Correspondent Contact Nick Tsc
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/26/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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