Transpara

GUDID 08719326450131

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

• Primary Device ID: 08719326450131
• NIH Device Record Key: 38bf96a1-63bc-46e7-8254-3da63e9072f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpara
• Version Model Number: 1.7.y
• Company DUNS: 491352982
• Company Name: Screenpoint Medical B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719326450131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210404

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-02
• Device Publish Date: 2021-07-23

On-Brand Devices [Transpara]

• 08719326450100: The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians
• 08719326450124: The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians
• 08719326450117: Transpara™ software is intended for use as a concurrent reading aid for physicians interpretin
• 08719326450131: Transpara® software is intended for use as a concurrent reading aid for physicians interpreting
• 08720387058013: Transpara® software is intended for use as a concurrent reading aid for physicians interpreting
• 08720387058044: Transpara® software is intended for use as a concurrent reading aid for physicians interpreting
• 08720387058051: Transpara® software is intended for use as a concurrent reading aid for physicians interpreting