FDA 510(k) Application Details - K230575

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K230575
Device Name	System, Image Processing, Radiological
Applicant	Limbus AI Inc. 2375 College Ave Regina S4P0S8 CA Other 510(k) Applications for this Company
Contact	Jon Giambattista Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2023
Decision Date	04/07/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review