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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241982
Device Name DeepFoqus (DeepFoqus-Accelerate)
Applicant
Foqus Technologies, Inc.
The Tannery, 151 Charles St. W Suite# 199
Kitchener,  CA N2G1H6
Applicant Contact Sadegh Raeisi
Correspondent
Foqus Technologies, Inc.
The Tannery, 151 Charles St. W Suite# 199
Kitchener,  CA N2G1H6
Correspondent Contact Sadegh Raeisi
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/05/2024
Decision Date 04/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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