# K221347: Transpara 1.7.2

- Pathway: 510(k) (Traditional)
- Applicant: Screenpoint Medical B.V.
- Decided: Aug 3, 2022 after 86 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210404: Transpara 1.7.0, Screenpoint Medical B.V. (2021) Summary page 5.

## Most influential descendants
- K241831: Transpara (2.1.0) (2024), 2 descendants of its own
- K260898: Transpara (2.1.0) (2026), 0 descendants of its own
- K251474: Median LCS (internal name) / eyonis LCS (trade name) (1.0) (2026), 0 descendants of its own
- K230096: Genius AI Detection 2.0 with CC-MLO Correlation (2023), 0 descendants of its own

## Indications for use
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@.

Source page: https://510kreport.com/device/K221347
Methodology: https://510kreport.com/methodology