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FDA 510(k) Application Details - K153547
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K153547
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, OH 44087 US
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Contact
Doug Thistlethwaite
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
12/11/2015
Decision Date
03/31/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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