FDA 510(k) Application Details - K954071

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K954071
Device Name System, Digital Image Communications, Radiological
Applicant IDX SYSTEMS CORP.
1400 SHELBURNE RD.
P.O. BOX 1070
BURLINGTON, VT 05402-1070 US
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Contact TANIA HORTON
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 08/30/1995
Decision Date 02/27/1996
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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