510(k) K103606 ยท IYE Accelerator, Linear, Medical
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Apr 15, 2011 |
| Received | Dec 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2020 | Siemens Medical Solutions USA, Inc ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Terminated |
IYE | None listed |
| Jul 26, 2016 | Siemens Medical Solutions USA, Inc ARTISTE, Accelerator, Linear, Medical
The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treat Terminated |
IYE | None listed |
| Sep 24, 2015 | Siemens Medical Solutions USA, Inc ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer
Product Usage:
The intended use of the SIEMENS branded AR Terminated |
IYE | None listed |
| Apr 26, 2013 | Siemens Medical Solutions USA, Inc Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108
on Siemens ARTISTE, ONCOR and PRIMUS systems.
ARTISTE, ONCOR and PRIMUS family of l Terminated |
IYE | None listed |
| Jul 24, 2012 | Siemens Medical Solutions USA, Inc ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are Terminated |
IYE | None listed |
| May 3, 2012 | Siemens Medical Solutions USA, Inc Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table Terminated |
IYE | None listed |
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS.
This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncol Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.