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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 K240094
Device Name LumiNE US; Lumi
Applicant
Augmedit B.V.
Galerij 15
Naarden,  NL 1411 LH
Applicant Contact Claartje Ypma
Correspondent
Augmedit B.V.
Galerij 15
Naarden,  NL 1411 LH
Correspondent Contact Claartje Ypma
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received01/12/2024
Decision Date 09/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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