FDA 510(k) Application Details - K193116

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K193116
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	ASG Superconductors S.p.A. Corso Ferdinando Maria Perrone 73/R Genova 16152 IT Other 510(k) Applications for this Company
Contact	DeBenedetti Luisella 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	11/12/2019
Decision Date	12/20/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review