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FDA 510(k) Application Details - K972366
Device Classification Name
System, Digital Image Communications, Radiological
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510(K) Number
K972366
Device Name
System, Digital Image Communications, Radiological
Applicant
IMNET SYSTEMS, INC.
3015 WINDWARD PLAZA
WINDWARD FAIRWAYS II
ALPHARETTA, GA 30202 US
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Contact
WI8LLIAM G BAIN
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Regulation Number
892.2020
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Classification Product Code
LMD
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More FDA Info for this Product Code
Date Received
06/25/1997
Decision Date
09/23/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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