Screenpoint Medical B.V.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Screenpoint Medical B.V.” (first 2018, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 130 days. Since 2017 the median was 130 days, against 142 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 147 |
| 2019 | 1 | 110 |
| 2020 | 1 | 104 |
| 2021 | 1 | 112 |
| 2022 | 1 | 86 |
| 2023 | 1 | 151 |
| 2024 | 1 | 153 |
| 2025 | 0 | — |
| 2026 | 1 | 149 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Screenpoint Medical B.V. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 7 | 7 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (8)
Most recent Screenpoint Medical B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260898 | Transpara (2.1.0) | QDQ | 2026-08-14 | 149 |
| K241831 | Transpara (2.1.0) | QDQ | 2024-11-25 | 153 |
| K232096 | Transpara Density 1.0.0 | QIH | 2023-12-11 | 151 |
| K221347 | Transpara 1.7.2 | QDQ | 2022-08-03 | 86 |
| K210404 | Transpara 1.7.0 | QDQ | 2021-06-02 | 112 |
| K193229 | Transpara | QDQ | 2020-03-05 | 104 |
| K192287 | Transpara | QDQ | 2019-12-10 | 110 |
| K181704 | Transpara | QDQ | 2018-11-21 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Screenpoint Medical B.V..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Screenpoint Medical B.V.?
FDA lists 8 510(k) clearances under the applicant name “Screenpoint Medical B.V.” (first 2018, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Screenpoint Medical B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Screenpoint Medical B.V. is 130 days. Since 2017: 130 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Screenpoint Medical B.V.?
The most frequent FDA product codes under this applicant name are QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, 7); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 8 Screenpoint Medical B.V. clearances with predicates and recalls
- Run predicate analysis for product code QDQ, Screenpoint Medical B.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.