FDA 510(k) Application Details - K141302

Device Classification Name System, Image Processing, Radiological

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510(K) Number K141302
Device Name System, Image Processing, Radiological
Applicant VITAL IMAGES, INC.
5850 Opus Pkwy Ste 300
MINNETONKA, MN 55343 US
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Contact PARTHIV SHAH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/19/2014
Decision Date 08/01/2014
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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