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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K223754
Device Name BraveCX
Applicant
Bering Ltd
54 Portland Place, 2nd Floor
London,  GB W1B 1DY
Applicant Contact Drozdov Ignat
Correspondent
Dawa Medical LLC
7320 NW 12th Street Suite 103
Miami,  FL  33126
Correspondent Contact Stephan Toupin
Regulation Number892.2080
Classification Product Code
QFM  
Date Received12/15/2022
Decision Date 11/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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