FDA 510(k) Application Details - K060378

Device Classification Name System, Image Processing, Radiological

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510(K) Number K060378
Device Name System, Image Processing, Radiological
Applicant VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA, MN 55343 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 02/14/2006
Decision Date 03/09/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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