FDA 510(k) Application Details - K061913

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K061913
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	ION BEAM APPLICATIONS S.A. 1500 MARKET STREET CENTRE SQUARE WEST, 38TH FLOOR PHILADELPHIA, PA 19102 US Other 510(k) Applications for this Company
Contact	JOHN REISS Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	LHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2006
Decision Date	07/28/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review