FDA 510(k) Application Details - K143345

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K143345
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	GE HEALTHCARE JAPAN CORPORATION 7-127, Asahigaoka 4-chome HINO-SHI 191-8503 JP Other 510(k) Applications for this Company
Contact	Toru Shimizu 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	11/21/2014
Decision Date	07/10/2015
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