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FDA 510(k) Application Details - K163116
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K163116
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best 5684PC NL
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Contact
Ruojuan Zhang
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
11/07/2016
Decision Date
01/06/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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