FDA 510(k) Application Details - K231871

Device Classification Name	More FDA Info for this Device
510(K) Number	K231871
Device Name	Radify Triage
Applicant	Envisionit Deep AI Ltd Coveham House, Downside Bridge Road Cobham KT11 3EP GB Other 510(k) Applications for this Company
Contact	Jaishree Naidoo 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	06/26/2023
Decision Date	01/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review