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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 K071154
Device Name SUPERSTAR 0.35T MRI SYSTEM
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
NO.3-11, WENHUA ROAD
HEPING DISTRICT
SHENYANG, LIAONING,  CN 110004
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/25/2007
Decision Date 05/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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