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510(k) K071154

SUPERSTAR 0.35T MRI SYSTEM by Neusoft Medical Systems Co., Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2007
Date Received
April 25, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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