FDA 510(k) Application Details - K240942

Device Classification Name	More FDA Info for this Device
510(K) Number	K240942
Device Name	CINA-CSpine
Applicant	Avicenna.AI Espace Mistral B, 375 avenue du Mistral 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	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2024
Decision Date	09/12/2024
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