FDA 510(k) Application Details - K173507

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K173507
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou 215024 CN Other 510(k) Applications for this Company
Contact	Gordon Shu 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	11/13/2017
Decision Date	06/15/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review