510(k) K190887 ยท HAW Neurological Stereotaxic Instrument
Leksell Vantage Stereotactic System
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Aug 1, 2019 |
| Received | Apr 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Elekta, Inc. Brand Name: Leksell Vantage Arc System
REF: 1053958 Open, Classified |
HAW | None listed |
| Nov 5, 2025 | Elekta, Inc. Brand Name: Leksell Stereotactic System
Product Name: Leksell Vantage Stereotactic System
Software Version: n/a
Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is tar Open, Classified |
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.