FDA 510(k) Application Details - K242825

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K242825
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Prenuvo 2727 El Camino Real Redwood City, CA 94061 US Other 510(k) Applications for this Company
Contact	Sam Hashemi 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	09/18/2024
Decision Date	01/17/2025
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