FDA 510(k) Application Details - K072821

Device Classification Name System, Image Processing, Radiological

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510(K) Number K072821
Device Name System, Image Processing, Radiological
Applicant VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA, MN 55343-4414 US
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Contact TIMOTHY J KAPPERS
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 10/02/2007
Decision Date 02/20/2008
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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