510(k) K253092 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Argos Infinity (Rev. 1.0)
| Applicant | Retia Medical Systems, Inc., White Plains NY, US |
| Decision | Substantially Equivalent, Feb 13, 2026 |
| Received | Sep 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253092
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.