FDA 510(k) Application Details - K954567

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K954567
Device Name System, Digital Image Communications, Radiological
Applicant RADIOLOGY TELENETWORK INTL.
2600 VIRGINIA AVE., N.W.
SUITE 1000
WASHINGTON, DC 20037-1905 US
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Contact MARTIN J GAYNES
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 09/29/1995
Decision Date 04/12/1996
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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