FDA 510(k) Application Details - K034051

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K034051
Device Name	Accelerator, Linear, Medical
Applicant	3D LINE USA, INC. 12100 SUNSET HILLS ROAD SUITE 150 RESTON, VA 20190 US Other 510(k) Applications for this Company
Contact	NADER SALEHI Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2003
Decision Date	04/05/2004
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