510(k) K183037 ยท MUJ System, Planning, Radiation Therapy Treatment
Monaco RTP System
| Applicant | Elekta, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Dec 4, 2018 |
| Received | Nov 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2021 | Elekta Inc Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | None listed |
| Jul 26, 2021 | Elekta Inc Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Open, Classified |
MUJ | None listed |
| Apr 16, 2020 | Elekta Inc Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation the Open, Classified |
MUJ | None listed |
| Nov 22, 2019 | Elekta Inc Monaco Radiation Treatment Planning System (RTP) System Open, Classified |
MUJ | None listed |
| Sep 4, 2019 | Elekta Inc Monaco RTP System, 5.40 Unity, radiation treatment planning system
Product Usage:
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy Open, Classified |
MUJ | None listed |
| Feb 8, 2019 | Elekta, Inc. Monaco Radiation Treatment Planning (RTP) System Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.