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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 K223646
Device Name IB Lab LAMA
Applicant
IB Lab GmbH
Zehetnergasse 6/2/2
Vienna,  AT 1140
Applicant Contact Richard Ljuhar
Correspondent
IB Lab GmbH
Zehetnergasse 6/2/2
Vienna,  AT 1140
Correspondent Contact Richard Ljuhar
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/06/2022
Decision Date 06/16/2023
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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