FDA 510(k) Application Details - K230082

Device Classification Name	More FDA Info for this Device
510(K) Number	K230082
Device Name	Auto Segmentation
Applicant	GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 US Other 510(k) Applications for this Company
Contact	Niki Mavrodieva 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	01/11/2023
Decision Date	05/04/2023
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