ADAS 3D

System, Image Processing, Radiological

Galgo Medical S.L

The following data is part of a premarket notification filed by Galgo Medical S.l with the FDA for Adas 3d.

Pre-market Notification Details

Device IDK191125
510k NumberK191125
Device Name:ADAS 3D
ClassificationSystem, Image Processing, Radiological
Applicant Galgo Medical S.L C/Comte D'Urgell, 143, 4B Barcelona,  ES 08036
ContactAntoni Riu
CorrespondentAntoni Riu
Galgo Medical S.L C/Comte D'Urgell, 143, 4B Barcelona,  ES 08036
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-29
Decision Date2020-01-15

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