FDA 510(k) Application Details - K240612

Device Classification Name	More FDA Info for this Device
510(K) Number	K240612
Device Name	CINA-VCF
Applicant	Avicenna.AI ZI Athelia, 297 Av. du Mistral BΓt. A, La Ciotat 13600 FR Other 510(k) Applications for this Company
Contact	Stephane Berger Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2024
Decision Date	05/31/2024
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