FDA 510(k) Application Details - K241837

Device Classification Name	More FDA Info for this Device
510(K) Number	K241837
Device Name	Limbus Contour
Applicant	Limbus AI Inc. 2431 Glamis Place Regina S4N3K9 CA Other 510(k) Applications for this Company
Contact	Jonathan Giambattista Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2024
Decision Date	10/09/2024
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