FDA 510(k) Application Details - K203279

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K203279
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Heuron Co., Ltd. 10th Floor, 7, Mirae-ro, Namdong-gu Incheon 21558 KR Other 510(k) Applications for this Company
Contact	Dong Hoon Shin 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	11/06/2020
Decision Date	07/12/2022
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