510(k) K090683 ยท IYE Accelerator, Linear, Medical
SYNGO RT THERAPIST CONNECT
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | Mar 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090683
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2016 | Siemens Medical Solutions USA, Inc Syngo RT Therapist, Accelerator, Linear, Medical
Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It al 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 |
| Mar 21, 2012 | Siemens Medical Solutions USA, Inc MOSAIQ System;
customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System.
MOSAIQ Oncology informatio Terminated |
IYE | None listed |
| Mar 4, 2011 | Siemens Medical Solutions USA, Inc Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Co Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.