FDA 510(k) Application Details - K223439

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K223439
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	GE Healthcare (Tianjin) Company Limited No. 266 Jingsan Road,Tianjin Airport Economic Area Tianjin 300308 CN Other 510(k) Applications for this Company
Contact	Huande Li Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2022
Decision Date	02/13/2023
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