Giotto Class (Models - 3000X-YY And 4000X-YY)

Full Field Digital, System, X-ray, Mammographic


The following data is part of a premarket notification filed by Ims Giotto S.p.a. with the FDA for Giotto Class (models - 3000x-yy And 4000x-yy).

Pre-market Notification Details

Device IDK200424
510k NumberK200424
Device Name:Giotto Class (Models - 3000X-YY And 4000X-YY)
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant IMS GIOTTO S.p.A. Via Sagittario 5 Sasso Marconi,  IT 40037
ContactAntonella Rossi
CorrespondentMarisa Testa
THEMA SRL Via Saragat, 5 Imola,  IT 40026
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-20
Decision Date2020-06-18

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