# K181704: Transpara

- Pathway: 510(k) (Traditional)
- Applicant: Screenpoint Medical B.V.
- Decided: Nov 21, 2018 after 147 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: 1 generation back to DEN180005 (2018). 1 ancestor in all.
32 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180005: OsteoDetect, Imagen Technologies, Inc. (2018) Summary page 7.

## Most influential descendants
- K193229: Transpara (2020), 9 descendants of its own
- K192287: Transpara (2019), 6 descendants of its own
- K211678: Lunit INSIGHT MMG (2021), 5 descendants of its own
- K210404: Transpara 1.7.0 (2021), 5 descendants of its own
- K221347: Transpara 1.7.2 (2022), 4 descendants of its own

## Indications for use
The ScreenPoint Transpara™ system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications; region‐based scores, displayed upon the physician’s query, indicating the likelihood that cancer is present in specific regions; and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara™.

Source page: https://510kreport.com/device/K181704
Methodology: https://510kreport.com/methodology