FDA 510(k) Application Details - K243446

Device Classification Name	More FDA Info for this Device
510(K) Number	K243446
Device Name	3DXR
Applicant	GE Medical Systems SCS 283 Rue De La Miniere Buc 78530 FR Other 510(k) Applications for this Company
Contact	Ning WEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2024
Decision Date	02/25/2025
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