Pristina Serena Bright

Full Field Digital, System, X-ray, Mammographic

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Pristina Serena Bright.

Pre-market Notification Details

Device IDK193334
510k NumberK193334
Device Name:Pristina Serena Bright
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant GE Healthcare 283 Rue De La Miniere Buc,  FR 78530
ContactBarthelemy Arman
CorrespondentBarthelemy Arman
GE Healthcare 283 Rue De La Miniere Buc,  FR 78530
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-05-15

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