FDA 510(k) Application Details - K241982

Device Classification Name	More FDA Info for this Device
510(K) Number	K241982
Device Name	DeepFoqus (DeepFoqus-Accelerate)
Applicant	Foqus Technologies Inc. The Tannery, 151 Charles St W Suite# 199 Kitchener N2G1H6 CA Other 510(k) Applications for this Company
Contact	Sadegh Raeisi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2024
Decision Date	04/04/2025
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