FDA 510(k) Application Details - K970641

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K970641
Device Name System, Digital Image Communications, Radiological
Applicant RADIOLOGY INFORMATION SYSTEMS, INC.
2004 ADAMS HILL RD.
VIENNA, VA 22182 US
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Contact JOE S PI
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 02/20/1997
Decision Date 05/02/1997
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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