FDA 510(k) Application Details - K191944

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K191944
Device Name	Accelerator, Linear, Medical
Applicant	DOSIsoft 45/47, Avenue Carnot Cachan 94230 FR Other 510(k) Applications for this Company
Contact	Marc Usynski Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2019
Decision Date	10/24/2019
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