FDA 510(k) Application Details - K092365

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K092365
Device Name	System, X-Ray, Tomography, Computed
Applicant	SUPERDIMENSION, LTD. 161 CHESHIRE LANE NORTH, SUITE 100 MINNEAPOLIS, MN 55441-5433 US Other 510(k) Applications for this Company
Contact	JONATHAN KOVACH 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	08/05/2009
Decision Date	09/04/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review