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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 K093984
Device Name PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
Applicant
Time Medical Limited
Suite 5d,#19, Ln. 999
Zhongshan Rd.(S-2)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Time Medical Limited
Suite 5d,#19, Ln. 999
Zhongshan Rd.(S-2)
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/24/2009
Decision Date 03/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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