FDA 510(k) Application Details - K013535

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K013535
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	3D LINE USA, INC. 2807 OLD COURT RD. BALTIMORE, MD 21208 US Other 510(k) Applications for this Company
Contact	KAREN RIGAMONTI Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2001
Decision Date	01/18/2002
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