Kinepict Medical Imaging Tool Version V2.2

System, Image Processing, Radiological

Kinepict Health Ltd

The following data is part of a premarket notification filed by Kinepict Health Ltd with the FDA for Kinepict Medical Imaging Tool Version V2.2.

Pre-market Notification Details

Device IDK190993
510k NumberK190993
Device Name:Kinepict Medical Imaging Tool Version V2.2
ClassificationSystem, Image Processing, Radiological
Applicant Kinepict Health Ltd Kelta K Z Budakeszi,  HU 2092
ContactLilla Strobel
CorrespondentLilla Strobel
Kinepict Health Ltd Kelta K Z Budakeszi,  HU 2092
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-16
Decision Date2020-03-05

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