FDA 510(k) Application Details - K980684

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K980684
Device Name System, Digital Image Communications, Radiological
Applicant I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO L4V 1S7 CA
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Contact CAROL NAKAGAWA
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 02/23/1998
Decision Date 05/06/1998
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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