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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Elucid Bioimaging Inc. with 6 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 29, 2026: Elucid FFR-IQ (B.1).
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.
| Sep 29, 2026 | Elucid FFR-IQ (B.1)K262015 · PJA | 510(k) clearances |
| Sep 18, 2026 | Elucid PlaqueIQK261855 · LLZ | 510(k) clearances |
| Sep 12, 2024 | Elucid PlaqueIQK241524 · LLZ | 510(k) clearances |
| Jun 17, 2022 | ElucidVivo A.3K221463 · LLZ | 510(k) clearances |
| Jun 17, 2022 | ElucidVivo A.3K221463 · Radiology | AI-enabled devices |
| Dec 21, 2018 | vascuCAPK183012 · LLZ | 510(k) clearances |
| Dec 21, 2018 | vascuCAPK183012 · Radiology | AI-enabled devices |
| May 24, 2017 | vascuCAPK163071 · 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
