FDA 510(k) Application Details - K161157

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K161157
Device Name	System, X-Ray, Tomography, Computed
Applicant	VITAL IMAGES, INC. 5850 OPUS PARKWAY SITE 300 Minnetonka, MN 55343-4414 US Other 510(k) Applications for this Company
Contact	Alexis Erazo 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	04/25/2016
Decision Date	11/03/2016
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