510(k) K142434 ยท IYE Accelerator, Linear, Medical
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
| Applicant | Siemens Medical Solutions USA, Inc., Martinez CA, US |
| Decision | Substantially Equivalent, Nov 21, 2014 |
| Received | Aug 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2022 | Siemens Medical Solutions USA, Inc ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version
4.3.1 MR3.
Material Number: 8162815
Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electro Open, Classified |
IYE | None listed |
| Dec 9, 2021 | Siemens Medical Solutions USA, Inc ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Model Number: 8162815 Terminated |
IYE | None listed |
| Oct 27, 2015 | Siemens Medical Solutions USA, Inc ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of Terminated |
IYE | None listed |
| Oct 6, 2015 | Siemens Medical Solutions USA, Inc Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In a Terminated |
IYE | None listed |
| Jan 26, 2015 | Siemens Medical Solutions USA, Inc Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatm Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.