FDA 510(k) Application Details - K022789

Device Classification Name System, Image Processing, Radiological

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510(K) Number K022789
Device Name System, Image Processing, Radiological
Applicant VIATRONIX, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact JEFF D RONGERO
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/22/2002
Decision Date 09/06/2002
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 Y
Expedited Review



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