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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K191125
Device Name ADAS 3D
Applicant
Galgo Medical S.L
C/Comte d'Urgell, 143, 4B
Barcelona,  ES 08036
Applicant Contact Antoni Riu
Correspondent
Galgo Medical S.L
C/Comte d'Urgell, 143, 4B
Barcelona,  ES 08036
Correspondent Contact Antoni Riu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/29/2019
Decision Date 01/15/2020
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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