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510(k) K082485

MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A by Neusoft Medical Systems Co., Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2008
Date Received
August 28, 2008
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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