510(k) K171123 ยท HAW Neurological Stereotaxic Instrument
Leksell Vantage Stereotactic System
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Sep 15, 2017 |
| Received | Apr 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2020 | Elekta Instrument AB Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 Terminated |
HAW | None listed |
| Apr 29, 2020 | Elekta Inc Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.