510(k) K972275 ยท IYE Accelerator, Linear, Medical
LANTIS TREATSTATION
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Sep 8, 1997 |
| Received | Jun 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972275
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2019 | Siemens Medical Solutions USA, Inc Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. Thi Terminated |
IYE | None listed |
| Aug 6, 2019 | Siemens Medical Solutions USA, Inc Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. Thi Terminated |
IYE | None listed |
| Aug 6, 2019 | Siemens Medical Solutions USA, Inc Lantis Commander, Model # 4503178 - Product Usage:
Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This e Terminated |
IYE | None listed |
| Mar 16, 2015 | Siemens Medical Solutions USA, Inc Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories Terminated |
IYE | None listed |
| Jun 20, 2014 | Siemens Medical Solutions USA, Inc Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander
The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.