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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 K240791
Device Name ADAS 3D
Applicant
Adas3D Medical S.L
Rambla Catalunya 53, 4H
Barcelona,  ES 08007
Applicant Contact Antoni Riu
Correspondent
Adas3D Medical S.L
Rambla Catalunya 53, 4H
Barcelona,  ES 08007
Correspondent Contact Antoni Riu
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received03/22/2024
Decision Date 09/09/2024
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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