EchoGo Pro

Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

Ultromics Ltd

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

Pre-market Notification Details

Device IDK201555
510k NumberK201555
Device Name:EchoGo Pro
ClassificationComputer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant Ultromics Ltd 4630 Kingsgate, Cascade Way, Oxford Business Park South Oxford,  GB Ox4 2su
ContactMelissa Clark
CorrespondentMelissa Clark
Ultromics Ltd 4630 Kingsgate, Cascade Way, Oxford Business Park South Oxford,  GB Ox4 2su
Product CodePOK  
CFR Regulation Number892.2060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-10
Decision Date2020-12-18

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