510(k) K223758 ยท JAK System, X-Ray, Tomography, Computed
Epione
| Applicant | Quantum Surgical Sas, Montpellier, FR |
| Decision | Substantially Equivalent, May 3, 2023 |
| Received | Dec 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2025 | QUANTUM SURGICAL SAS EPIONE Model 30-0001
UDI-DI code: 03760305400031
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, a Open, Classified |
JAK | None listed |
| Oct 9, 2024 | QUANTUM SURGICAL SAS The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrum Completed |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.