FDA 510(k) Application Details - K232231

Device Classification Name	More FDA Info for this Device
510(K) Number	K232231
Device Name	QP-Brain«
Applicant	Quibim S.L. Avenida Arag≤n 30, 13th Floor, Office I-J Valencia 46021 ES Other 510(k) Applications for this Company
Contact	Angel Alberich Bayarri 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	07/27/2023
Decision Date	12/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review