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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 K243684
Device Name BrightHeart View Classifier
Applicant
Brightheart
7-11 Blvd. Haussmann
Paris,  FR 75009
Applicant Contact Christophe Gardella
Correspondent
Brightheart
7-11 Blvd. Haussmann
Paris,  FR 75009
Correspondent Contact Christophe Gardella
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/29/2024
Decision Date 05/07/2025
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		 Yes
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