Transparency Registry · applicant
Screenpoint Medical B.V.: 8 FDA AI clearances
Every 510(k) clearance held by Screenpoint Medical B.V. under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| Transpara (2.1.0) | 2026-08-14 | QDQ |
| Transpara (2.1.0) | 2024-11-25 | QDQ |
| Transpara Density 1.0.0 | 2023-12-11 | QIH |
| Transpara 1.7.2 | 2022-08-03 | QDQ |
| Transpara 1.7.0 | 2021-06-02 | QDQ |
| Transpara | 2020-03-05 | QDQ |
| Transpara | 2019-12-10 | QDQ |
| Transpara | 2018-11-21 | QDQ |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Screenpoint Medical B.V.? The disclosure rows on your entries update free on submission of public links — start here.
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