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 IDK192287
510k NumberK192287
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2019-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08719326450124 K192287 000

Trademark Results [Transpara]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRANSPARA
TRANSPARA
97560177 not registered Live/Pending
CPS Technology Holdings LLC
2022-08-23
TRANSPARA
TRANSPARA
87822676 5906201 Live/Registered
Transpara, LLC
2018-03-06
TRANSPARA
TRANSPARA
87012066 not registered Dead/Abandoned
C.R. Laurence Co., Inc.
2016-04-24
TRANSPARA
TRANSPARA
86756857 4968025 Live/Registered
ScreenPoint Medical BV
2015-09-15
TRANSPARA
TRANSPARA
77818070 not registered Dead/Abandoned
Matakina Technology Limited
2009-09-02
TRANSPARA
TRANSPARA
71592472 0541135 Dead/Expired
BURLINGTON MILLS CORPORATION
1950-02-15

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