Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Tempus AILabelled by claude-sonnet-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 13, 2026, FDA's public records list Arterys with 8 510(k) clearances and 6 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 3, 2025: Tempus Pixel.
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 |
|---|---|---|
| Sep 3, 2025 | Tempus PixelK252539 · QIH | 510(k) clearances |
| Sep 3, 2025 | Tempus PixelK252539 · Radiology | AI-enabled devices |
| Mar 14, 2022 | Arterys MICAK203744 · QIH | 510(k) clearances |
| Mar 14, 2022 | Arterys MICAK203744 · Radiology | AI-enabled devices |
| Mar 25, 2020 | Arterys MICAK192437 · QIH | 510(k) clearances |
| Mar 25, 2020 | Arterys MICAK192437 · Radiology | AI-enabled devices |
| Oct 17, 2018 | Arterys MICAK182034 · LLZ | 510(k) clearances |
| Oct 17, 2018 | Arterys MICAK182034 · Radiology | AI-enabled devices |
| Jan 25, 2018 | Arterys Oncology DLK173542 · LLZ | 510(k) clearances |
| Jan 25, 2018 | Arterys Oncology DLK173542 · Radiology | AI-enabled devices |
| Jul 18, 2017 | Arterys ViewerK171544 · LLZ | 510(k) clearances |
| Jan 5, 2017 | Arterys Cardio DLK163253 · LLZ | 510(k) clearances |
| Jan 5, 2017 | Arterys Cardio DLK163253 · Radiology | AI-enabled devices |
| Oct 28, 2016 | Arterys Software v2.0K162513 · LLZ | 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
