FDA 510(k) Application Details - K151115

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151115
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 Parthiv Shah
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/27/2015
Decision Date 06/03/2015
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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