FDA 510(k) Application Details - K242054

Device Classification Name	More FDA Info for this Device
510(K) Number	K242054
Device Name	OptimMRI (v2)
Applicant	Rebrain, SAS Plateforme Technologique dÆInnovation BiomΘdicale (PTIB) H⌠pital Xavier Arnozan Avenue du Haut LΘvΩque Pessac 33600 FR Other 510(k) Applications for this Company
Contact	Thomas Queuche Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2024
Decision Date	08/12/2024
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