EchoGo Core

Automated Radiological Image Processing Software

Ultromics Ltd

The following data is part of a premarket notification filed by Ultromics Ltd with the FDA for Echogo Core.

Pre-market Notification Details

Device IDK191171
501k NumberK191171
Device Name:EchoGo Core
ClassificationAutomated Radiological Image Processing Software
Applicant Ultromics Ltd Stansfeld Park, Quarry Road Oxford,  GB Ox3 8sb
ContactMelissa Clark
CorrespondentMelissa Clark
Ultromics Ltd Stansfeld Park, Quarry Road Oxford,  GB Ox3 8sb
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-01
Decision Date2019-11-13

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