FDA 510(k) Application Details - K190664

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K190664
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	Brainlab AG Olof-Palme-Str. 9 Mⁿnchen 81829 DE Other 510(k) Applications for this Company
Contact	Rainer Birkenbach 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	03/15/2019
Decision Date	04/12/2019
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