Transpara

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

ScreenPoint Medical B.V.

The following data is part of a premarket notification filed by Screenpoint Medical B.v. with the FDA for Transpara.

Pre-market Notification Details

Device IDK193229
510k NumberK193229
Device Name:Transpara
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Applicant ScreenPoint Medical B.V. Mercator II, 7th Floor, Toernooiveld 300 Nijmegen,  NL 6525ec
ContactUmar Waqas
CorrespondentUmar Waqas
ScreenPoint Medical B.V. Mercator II, 7th Floor, Toernooiveld 300 Nijmegen,  NL 6525ec
Product CodeQDQ  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-22
Decision Date2020-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08719326450117 K193229 000

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