Medical device makerLabelled 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 Ceevra with 6 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Aug 25, 2026: Ceevra Reveal 4.
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 |
|---|---|---|
| Aug 25, 2026 | Ceevra Reveal 4K261595 · QIH | 510(k) clearances |
| Mar 4, 2025 | Ceevra Reveal 3+K243933 · QIH | 510(k) clearances |
| Mar 4, 2025 | Ceevra Reveal 3+K243933 · Radiology | AI-enabled devices |
| Dec 5, 2023 | Ceevra Reveal 3+K233568 · QIH | 510(k) clearances |
| Dec 5, 2023 | Ceevra Reveal 3+K233568 · Radiology | AI-enabled devices |
| Apr 25, 2023 | Ceevra Reveal 3K222676 · QIH | 510(k) clearances |
| Apr 25, 2023 | Ceevra Reveal 3K222676 · Radiology | AI-enabled devices |
| Jul 10, 2018 | Ceevra Reveal 2.0K173274 · LLZ | 510(k) clearances |
| Aug 3, 2017 | Clarity RevealK171356 · 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
