Data / Medical devices / Netherlands / Screenpoint Medical
Screenpoint Medical: FDA-registered device maker in Nijmegen Gelderland, Netherlands, 8 510(k) clearances
Screenpoint Medical is registered with the FDA (registration 3015173173) in Nijmegen Gelderland, Netherlands. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015173173
- Address
- Mercator II, 7th floor Toernooiveld 300, Nijmegen Gelderland, Netherlands, 6525 EC
- Owner or operator
- ScreenPoint Medical (10059521)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 30, 2019
- Registered through
- 2026
- Brand names listed
- Transpara, Transpara 1.7.2, Transpara 1.7.y, Transpara SR Converter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2026 | K260898 | Transpara (2.1.0) | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| November 25, 2024 | K241831 | Transpara (2.1.0) | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| December 11, 2023 | K232096 | Transpara Density 1.0.0 | QIH | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| August 3, 2022 | K221347 | Transpara 1.7.2 | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| June 2, 2021 | K210404 | Transpara 1.7.0 | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| March 5, 2020 | K193229 | Transpara | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| December 10, 2019 | K192287 | Transpara | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
| November 21, 2018 | K181704 | Transpara | QDQ | Substantially Equivalent | Screenpoint Medical B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- All makers of System, Digital Image Communications, Radiological
- All makers of Automated Radiological Image Processing Software
Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.