Transpara

GUDID 08719326450117

Transpara™ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara™.

Screenpoint Medical B.V.

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software
Primary Device ID08719326450117
NIH Device Record Key29989b97-665d-4eee-9678-ca584b5a1282
Commercial Distribution StatusIn Commercial Distribution
Brand NameTranspara
Version Model Number1.x.y
Company DUNS491352982
Company NameScreenpoint Medical B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com
Phone+31242020028
Emailsupport@screenpointmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108719326450117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-24
Device Publish Date2020-03-16

On-Brand Devices [Transpara]

08719326450100The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians
08719326450124The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians
08719326450117Transpara™ software is intended for use as a concurrent reading aid for physicians interpretin
08719326450131Transpara® software is intended for use as a concurrent reading aid for physicians interpreting
08720387058013Transpara® software is intended for use as a concurrent reading aid for physicians interpreting
08720387058044Transpara® software is intended for use as a concurrent reading aid for physicians interpreting

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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