FDA 510(k) Application Details - K233669

Device Classification Name	More FDA Info for this Device
510(K) Number	K233669
Device Name	OEC 3D
Applicant	GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Shawn Quigley Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2023
Decision Date	03/28/2024
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