FDA 510(k) Application Details - K981678

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K981678
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	ROSSES MEDICAL SYSTEMS 10620 GUILFORD RD., STE. 201 JESSUP, MD 20794 US Other 510(k) Applications for this Company
Contact	RENE SPECTOR 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	05/12/1998
Decision Date	12/11/1998
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