FDA 510(k) Application Details - K222639

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K222639
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	VHA DEAN 810 Vermont Ave NW Washington, DC 20420 US Other 510(k) Applications for this Company
Contact	Beth Ripley Other 510(k) Applications for this Contact
Regulation Number	892.5710   More FDA Info for this Regulation Number
Classification Product Code	IXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2022
Decision Date	11/04/2022
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