Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled 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 13, 2026, FDA's public records list Ultromics with 6 510(k) clearances and 5 AI-enabled devices. The most recent is a 510(k) clearance dated Nov 15, 2024: EchoGo Amyloidosis (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.
| Date | Record | Source |
|---|---|---|
| Nov 15, 2024 | EchoGo Amyloidosis (1.0)K240860 · SDJ | 510(k) clearances |
| Nov 15, 2024 | EchoGo Amyloidosis (1.0)K240860 · Cardiovascular | AI-enabled devices |
| Sep 23, 2024 | EchoGo Heart Failure (2.0)K240013 · QUO | 510(k) clearances |
| Sep 23, 2024 | EchoGo Heart Failure (2.0)K240013 · Cardiovascular | AI-enabled devices |
| Nov 23, 2022 | EchoGo Heart FailureK222463 · QUO | 510(k) clearances |
| Dec 20, 2021 | EchoGo Core (2.0)K213275 · QIH | 510(k) clearances |
| Dec 20, 2021 | EchoGo Core (2.0)K213275 · Radiology | AI-enabled devices |
| Dec 18, 2020 | EchoGo ProK201555 · POK | 510(k) clearances |
| Dec 18, 2020 | EchoGo ProK201555 · Radiology | AI-enabled devices |
| Nov 13, 2019 | EchoGo CoreK191171 · QIH | 510(k) clearances |
| Nov 13, 2019 | EchoGo CoreK191171 · 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
