Red Dot

Radiological Computer-assisted Prioritization Software For Lesions

Behold.AI Technologies Limited

The following data is part of a premarket notification filed by Behold.ai Technologies Limited with the FDA for Red Dot.

Pre-market Notification Details

Device IDK191556
510k NumberK191556
Device Name:Red Dot
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant Behold.AI Technologies Limited 91-97 Bohemia Road St. Leonards-on-sea,  GB Tn37 6rj
ContactSimon Rasalingham
CorrespondentJohn J. Smith
Hogan Lovells US LPP 555 13th Street, NW Washington,  DC  20004
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-12
Decision Date2020-02-28

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