Senographe Pristina

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 Senographe Pristina.

Pre-market Notification Details

Device IDK211725
510k NumberK211725
Device Name:Senographe Pristina
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 Received2021-06-04
Decision Date2021-08-06

Trademark Results [Senographe Pristina]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SENOGRAPHE PRISTINA
SENOGRAPHE PRISTINA
86652853 5261610 Live/Registered
General Electric Company
2015-06-05

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