Blue Phantom PT

System, Radiation Therapy, Charged-particle, Medical

IBA Dosimetry GmbH

The following data is part of a premarket notification filed by Iba Dosimetry Gmbh with the FDA for Blue Phantom Pt.

Pre-market Notification Details

Device IDK191821
510k NumberK191821
Device Name:Blue Phantom PT
ClassificationSystem, Radiation Therapy, Charged-particle, Medical
Applicant IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck,  DE 90592
ContactAndreas Suchi
CorrespondentOlaf Teichert
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeLHN  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-07-08
Decision Date2020-01-23

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