FDA 510(k) Application Details - K201616

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K201616
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	SyntheticMR AB Storgatan 11 Linkoping SE-582 23 SE Other 510(k) Applications for this Company
Contact	Raymond Kelly 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	06/15/2020
Decision Date	07/28/2020
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