FDA 510(k) Application Details - K091629

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K091629
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	ION BEAM APPLICATIONS S.A. 3 CHEMIN DU CYCLOTRON LOUVAIN-LA-NEUVE, BE 1348 BE Other 510(k) Applications for this Company
Contact	YVES JONGEN 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	06/03/2009
Decision Date	08/11/2009
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	Y
Expedited Review