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FDA 510(k) Application Details - K012154
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K012154
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
AURORA IMAGING TECHNOLOGY, INC.
39 HIGH ST.
NORTH ANDOVER, MA 01845 US
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Contact
JAMES J ROGERS
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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
07/11/2001
Decision Date
09/19/2001
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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