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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 K242500
Device Name LARALAB
Applicant
LARALAB GmbH
Herzog-Heinrich-Str.13, 80336
Munich,  DE
Applicant Contact Julian Bernard
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/22/2024
Decision Date 04/16/2025
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		 No
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