510(k) K190178 ยท MUJ System, Planning, Radiation Therapy Treatment
Monaco RTP System
| Applicant | Elekta, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Mar 29, 2019 |
| Received | Feb 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190178
| 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 |
| 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, 5.50/5.51, 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 |
| Aug 23, 2019 | Elekta, Inc. Monaco Radiation Treatment Planning System (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.