FDA 510(k) Application Details - K141069

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K141069
Device Name	System, X-Ray, Tomography, Computed
Applicant	IMBIO LLC 227 COLFAX AVE N SUITE 144 MINNEAPOLIS, MN 55405 US Other 510(k) Applications for this Company
Contact	JASON SHEARD 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	04/24/2014
Decision Date	09/17/2014
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