FDA 510(k) Application Details - K222259

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K222259
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Time Medical Limited Flat/Rm 301, 3/F 20E, 20 Science Park East Ave Hong Kong Science Park Shatin, Hong Kong CN Other 510(k) Applications for this Company
Contact	Nick Tse 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	07/28/2022
Decision Date	02/21/2023
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