FDA 510(k) Application Details - K200282

Device Classification Name	System, Radiation Therapy, Charged-Particle, Medical   More FDA Info for this Device
510(K) Number	K200282
Device Name	System, Radiation Therapy, Charged-Particle, Medical
Applicant	Orfit Industries NV 9A, Vosveld Wijnegem 2110 BE Other 510(k) Applications for this Company
Contact	Eddy Marivoet 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	02/04/2020
Decision Date	04/08/2020
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