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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
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