FDA 510(k) Application Details - K151919

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K151919
Device Name	System, X-Ray, Tomography, Computed
Applicant	VITAL IMAGES, INC. 5850 OPUS PARKWAY, SUITE 300 MINNETONKA, MN 55343-4414 US Other 510(k) Applications for this Company
Contact	KATIE RYAN Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2015
Decision Date	10/10/2015
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