FX SPS

System, Image Processing, Radiological

Pixee Medical

The following data is part of a premarket notification filed by Pixee Medical with the FDA for Fx Sps.

Pre-market Notification Details

Device IDK213922
510k NumberK213922
Device Name:FX SPS
ClassificationSystem, Image Processing, Radiological
Applicant Pixee Medical 18 Rue Alain Savary Besancon,  FR 25000
ContactAgathe Joet
CorrespondentAgathe Joet
Pixee Medical 18 Rue Alain Savary Besancon,  FR 25000
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-15
Decision Date2022-07-22

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