FDA 510(k) Application Details - K100056

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K100056
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	MEDCOM GMBH 12 RUNDETURMSTRASSE DARMSTADT, HESSEN 64283 DE Other 510(k) Applications for this Company
Contact	STEFAN WALTER 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	01/08/2010
Decision Date	05/07/2010
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