SUPERSTAR 0.35T MRI SYSTEM

System, Nuclear Magnetic Resonance Imaging

NEUSOFT MEDICAL SYSTEMS CO., LTD.

The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Superstar 0.35t Mri System.

Pre-market Notification Details

Device IDK071154
510k NumberK071154
Device Name:SUPERSTAR 0.35T MRI SYSTEM
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant NEUSOFT MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning,  CN 110004
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-04-25
Decision Date2007-05-10
Summary:summary

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