510(k) K242966 · DQO Catheter, Intravascular, Diagnostic
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
| Applicant | Gentuity, LLC, Sudbury MA, US |
| Decision | Substantially Equivalent, Jan 31, 2025 |
| Received | Sep 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2026 | Gentuity, LLC Gentuity HF-OCT Imaging System Model G10-01;
Software version 23.2.13; Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.