FDA 510(k) Application Details - K003230

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K003230
Device Name	System, X-Ray, Tomography, Computed
Applicant	VITAL IMAGES, INC. 3300 FERNBROOK LN. NORTH SUITE 200 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	ROBERT C SAMEC 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	10/16/2000
Decision Date	12/27/2000
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