Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in BelgiumLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list icometrix with 6 510(k) clearances and 5 AI-enabled devices. The most recent is a 510(k) clearance dated Nov 7, 2024: icobrain aria.
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 |
|---|---|---|
| Nov 7, 2024 | icobrain ariaK240712 · QBS | 510(k) clearances |
| Nov 7, 2024 | icobrain ariaK240712 · Radiology | AI-enabled devices |
| Feb 28, 2020 | icobrain-ctpK192962 · LLZ | 510(k) clearances |
| Feb 28, 2020 | icobrain-ctpK192962 · Radiology | AI-enabled devices |
| Dec 13, 2019 | IcobrainK192130 · LLZ | 510(k) clearances |
| Dec 13, 2019 | IcobrainK192130 · Radiology | AI-enabled devices |
| Nov 6, 2018 | icobrainK181939 · LLZ | 510(k) clearances |
| Nov 6, 2018 | icobrainK181939 · Radiology | AI-enabled devices |
| Mar 8, 2018 | icobrainK180326 · LLZ | 510(k) clearances |
| Aug 9, 2016 | icobrainK161148 · LLZ | 510(k) clearances |
| Aug 9, 2016 | icobrainK161148 · 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
