FDA 510(k) Application Details - K223875

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K223875
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Sino Canada Health Engineering Research Institute (Hefei) Ltd. (SCHERI) Building B5, National Health Industrial Park, High-tech Zone Hefei 230088 CN Other 510(k) Applications for this Company
Contact	Gong Zhang 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	12/23/2022
Decision Date	03/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review