# Screenpoint Medical B.V.

- Location (FDA's records): Nijmegen, NL
- FDA decisions: 8 (2018–2026): 8 510(k) clearances
- Product codes: QDQ (7), QIH (1)
- 510(k) review time since 2016: median 131 days, against 154 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Volpara Health Technologies Limited: 1 (https://510kreport.com/company/volpara-health-technologies)
- Imagen Technologies, Inc.: 1 (https://510kreport.com/company/imagen-technologies)

## Firms that cite its devices most
- Therapixel: 1 (https://510kreport.com/company/therapixel)
- Siemens Healthcare GmbH: 1 (https://510kreport.com/company/siemens-healthcare)
- Scanmed, LLC: 1 (https://510kreport.com/company/scanmed)
- Lunit, Inc.: 1 (https://510kreport.com/company/lunit)
- Median Technologies: 1 (https://510kreport.com/company/median-technologies)
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- DeepHealth, Inc.: 1 (https://510kreport.com/company/deephealth)
- Taihao Medical, Inc.: 1 (https://510kreport.com/company/taihao-medical)

## Its most-cited devices
- K181704: Transpara (2018), cited by 6
- K193229: Transpara (2020), cited by 2
- K241831: Transpara (2.1.0) (2024), cited by 2
- K221347: Transpara 1.7.2 (2022), cited by 2
- K210404: Transpara 1.7.0 (2021), cited by 1
- K192287: Transpara (2019), cited by 1

## Recent decisions
- K260898: Transpara (2.1.0) (Aug 14, 2026)
- K241831: Transpara (2.1.0) (Nov 25, 2024)
- K232096: Transpara Density 1.0.0 (Dec 11, 2023)
- K221347: Transpara 1.7.2 (Aug 3, 2022)
- K210404: Transpara 1.7.0 (Jun 2, 2021)
- K193229: Transpara (Mar 5, 2020)
- K192287: Transpara (Dec 10, 2019)
- K181704: Transpara (Nov 21, 2018)

Source page: https://510kreport.com/company/screenpoint-medical