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.

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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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<a href="https://healthcareaiops.com/registry/company/screenpoint-medical-b-v/" style="display:inline-block;border:1px solid #E3E5E8;border-left:3px solid #0F62FE;padding:6px 12px;font:600 12px sans-serif;color:#16191D;text-decoration:none">✓ 8 FDA AI clearances · Transparency Registry</a>

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