FDA 510(k) Application Details - K214093

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K214093
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	3D Systems 5381 S Alkire Circle Littleton, CO 80127 US Other 510(k) Applications for this Company
Contact	Benjamin Johnson 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	12/28/2021
Decision Date	03/30/2022
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