FDA 510(k) Application Details - K213305

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K213305
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Canon Medical Systems Corporation 1385 Shimoshigami Otawara-shi 324-8550 JP Other 510(k) Applications for this Company
Contact	Janine F. Reyes 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	10/04/2021
Decision Date	12/01/2021
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