FDA 510(k) Application Details - K241133

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K241133
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Esaote S.p.A. Via Melen 77 Genova 16152 IT Other 510(k) Applications for this Company
Contact	Alberto Carcagn∞ 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	04/24/2024
Decision Date	06/26/2024
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