FDA 510(k) Application Details - K250440

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K250440
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	Brainlab AG Olof-Palme-Str. 9 Munich 81829 DE Other 510(k) Applications for this Company
Contact	Sadwini Suresh 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	02/14/2025
Decision Date	06/17/2025
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