Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ScreenPoint Medical with 8 510(k) clearances and 7 AI-enabled devices. The most recent is a 510(k) clearance dated Aug 14, 2026: Transpara (2.1.0).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 14, 2026 | Transpara (2.1.0)K260898 · QDQ | 510(k) clearances |
| Nov 25, 2024 | Transpara (2.1.0)K241831 · QDQ | 510(k) clearances |
| Nov 25, 2024 | Transpara (2.1.0)K241831 · Radiology | AI-enabled devices |
| Dec 11, 2023 | Transpara Density 1.0.0K232096 · QIH | 510(k) clearances |
| Dec 11, 2023 | Transpara Density 1.0.0K232096 · Radiology | AI-enabled devices |
| Aug 3, 2022 | Transpara 1.7.2K221347 · QDQ | 510(k) clearances |
| Aug 3, 2022 | Transpara 1.7.2K221347 · Radiology | AI-enabled devices |
| Jun 2, 2021 | Transpara 1.7.0K210404 · QDQ | 510(k) clearances |
| Jun 2, 2021 | Transpara 1.7.0K210404 · Radiology | AI-enabled devices |
| Mar 5, 2020 | TransparaK193229 · QDQ | 510(k) clearances |
| Mar 5, 2020 | TransparaK193229 · Radiology | AI-enabled devices |
| Dec 10, 2019 | TransparaK192287 · QDQ | 510(k) clearances |
| Dec 10, 2019 | TransparaK192287 · Radiology | AI-enabled devices |
| Nov 21, 2018 | TransparaK181704 · QDQ | 510(k) clearances |
| Nov 21, 2018 | TransparaK181704 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
