FDA 510(k) Application Details - K013999

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K013999
Device Name	System, X-Ray, Tomography, Computed
Applicant	LODOX SYSTEMS (PTY) LTD. 177 EAST 79TH ST. SUITE 4 NEW YORK, NY 10021 US Other 510(k) Applications for this Company
Contact	BRADLEY SACKS 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	12/04/2001
Decision Date	08/06/2002
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