FDA 510(k) Application Details - K231420

Device Classification Name	More FDA Info for this Device
510(K) Number	K231420
Device Name	Aura 10 PET/CT
Applicant	XEOS Medical Ottergemsesteenweg-Zuid 808 Bus 358 Gent 9000 BE Other 510(k) Applications for this Company
Contact	Bjorn Delbeecke Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2023
Decision Date	08/10/2023
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