GammaTile

Source, Brachytherapy, Radionuclide

GT Medical Technologies

The following data is part of a premarket notification filed by Gt Medical Technologies with the FDA for Gammatile.

Pre-market Notification Details

Device IDK190839
510k NumberK190839
Device Name:GammaTile
ClassificationSource, Brachytherapy, Radionuclide
Applicant GT Medical Technologies 1809 S Holbrook Lane, Suite 107 Tempe,  AZ  85281
ContactJessica Newhard
CorrespondentJessica Newhard
GT Medical Technologies 1809 S Holbrook Lane, Suite 107 Tempe,  AZ  85281
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-01
Decision Date2020-01-23
Summary:summary

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