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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 K232410
Device Name SmartChest
Applicant
Milvue
29 Rue du Faubourg Saint Jacques
Paris,  FR 75014
Applicant Contact Oumaya Ibrahim
Correspondent
Cosm
45 Bartlett St.
San Francisco,  CA  94110
Correspondent Contact Rory Carrillo
Regulation Number892.2080
Classification Product Code
QFM  
Date Received08/10/2023
Decision Date 05/10/2024
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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