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FDA 510(k) Application Details - K964778
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K964778
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
HEALTH IMAGES, INC.
8601 DUNWOODY PLACE
SUITE 200
ATLANTA, GA 30350 US
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Contact
RICHARD E HALBACH
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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
11/27/1996
Decision Date
02/24/1997
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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