Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Arineta Ltd. with 5 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Apr 15, 2025: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option.
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.
| Date | Record | Source |
|---|---|---|
| Apr 15, 2025 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionK250650 · JAK | 510(k) clearances |
| Apr 15, 2025 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionK250650 · Radiology | AI-enabled devices |
| Jan 13, 2025 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionK241200 · JAK | 510(k) clearances |
| Jan 13, 2025 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionK241200 · Radiology | AI-enabled devices |
| Oct 13, 2023 | SpotLight/SpotLight Duo (with DLIR option)K230370 · JAK | 510(k) clearances |
| Oct 13, 2023 | SpotLight/SpotLight Duo (with DLIR option)K230370 · Radiology | AI-enabled devices |
| Dec 2, 2022 | CardioGrapheK213465 · JAK | 510(k) clearances |
| Aug 10, 2016 | SpotLight CTK161066 · JAK | 510(k) clearances |
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
