FDA 510(k) Application Details - K171778

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K171778
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Ivy Biomedical Systems, Inc 11 Business Park Drive Branford, CT 06405 US Other 510(k) Applications for this Company
Contact	Nicole Bush 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	06/15/2017
Decision Date	03/14/2018
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