FDA 510(k) Application Details - K231855

Device Classification Name	More FDA Info for this Device
510(K) Number	K231855
Device Name	QOCA« image Smart RT Contouring System
Applicant	Quanta Computer Inc. No. 188, Wenhua 2nd Rd Guishan Dist. Taoyuan City 33383 TW Other 510(k) Applications for this Company
Contact	Joe Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2023
Decision Date	02/13/2024
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