510(k) K123230 ยท IYE Accelerator, Linear, Medical
MOSAIQ ONCOLOGY INFORMATION SYSTEM
| Applicant | Impac Medical Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 12, 2012 |
| Received | Oct 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2018 | Elekta, Inc. MOSAIQ Oncology Information System and Sequencer
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare f Open, Classified |
IYE | None listed |
| Jun 21, 2017 | Elekta, Inc. MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher
Product Usage:
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports Terminated |
IYE | None listed |
| Jul 15, 2016 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | None listed |
| Nov 15, 2014 | Elekta, Inc. MOSAIQ
Product Usage:
MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be Terminated |
IYE | None listed |
| Jun 25, 2014 | Elekta, Inc. MOSAIQ
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ev Terminated |
IYE | None listed |
| Jun 16, 2014 | Elekta, Inc. MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiother Terminated |
IYE | None listed |
| Apr 10, 2013 | Siemens Medical Solutions USA, Inc ELEKTA MOSAIQ SW version below 2.41
Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation fo Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.