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FDA 510(k) Application Details - K180925
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K180925
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Road., Jiading Industrial District
Shanghai 201807 CN
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Contact
Shumei Wang
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
04/09/2018
Decision Date
06/06/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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