FDA 510(k) Application Details - K240582

Device Classification Name	More FDA Info for this Device
510(K) Number	K240582
Device Name	VEA Align; spineEOS
Applicant	EOS imaging 10 rue Mercoeur Paris 75011 FR Other 510(k) Applications for this Company
Contact	Moran Celestin 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	03/01/2024
Decision Date	06/25/2024
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