FDA 510(k) Application Details - K954691

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K954691
Device Name System, Digital Image Communications, Radiological
Applicant ACCESS RADIOLOGY CORP.
ONE FINANCIAL CENTER
BOSTON, MA 02111 US
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Contact CAROLYN S LANGER
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 10/11/1995
Decision Date 03/29/1996
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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