510(k) K140660 ยท IYE Accelerator, Linear, Medical
MOBIUS3D
| Applicant | Mobius Medical Systems, LP, Bellaire TX, US |
| Decision | Substantially Equivalent, Jun 24, 2014 |
| Received | Mar 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2017 | Mobius Medical Systems, LP Mobius3D
Product Usage:
Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.