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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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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