FDA 510(k) Application Details - K192426

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K192426
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	GE Healthcare(Tianjin) Company Limited No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin 300308 CN Other 510(k) Applications for this Company
Contact	Yuan Ma 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	09/05/2019
Decision Date	10/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review