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 13, 2026, FDA's public records list Gentuity with 4 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 23, 2026: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;.
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 |
|---|---|---|
| Mar 23, 2026 | Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;Class II · The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 | Device recalls |
| Jan 31, 2025 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterK242966 · DQO | 510(k) clearances |
| Aug 16, 2024 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))K242239 · NQQ | 510(k) clearances |
| Aug 8, 2023 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterK230620 · DQO | 510(k) clearances |
| Feb 20, 2020 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterK192922 · NQQ | 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
