FDA 510(k) Application Details - K003736

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K003736
Device Name	System, X-Ray, Tomography, Computed
Applicant	I.Z.I. CORP. 2624 LORD BALTIMORE DR. SUITE K OWINGS MILLS, MD 21244 US Other 510(k) Applications for this Company
Contact	HELEN ZINREICH 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	12/04/2000
Decision Date	01/18/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review