FDA 510(k) Application Details - K232641

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K232641
Device Name	System, Image Processing, Radiological
Applicant	Everrtech Software PVT LTD A306 Western Edge II Borivali East Mumbai 400066 IN Other 510(k) Applications for this Company
Contact	Josh Baker 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	08/30/2023
Decision Date	04/10/2024
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