Transpara

Primary DI
08720387058044
Brand
Transpara
Company
Screenpoint Medical B.V.
Model
2.Y.Z
Device description
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 thatcancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Published
2023-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232096000Transpara Density 1.0.0Screenpoint Medical B.V.2023-12-11QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720387058044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720387058044087203870580448720387058044

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
491352982
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720387058051Transpara2.Y.Z2024-11-28
08720387058013Transpara1.7.22023-03-03
08719326450131Transpara1.7.y2021-07-23
08719326450117Transpara1.x.y2020-03-16
08719326450124Transpara1.5.0 2D2019-12-12
08719326450100Transpara1.3.y2019-02-04

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