510(k) K151233 ยท MUJ System, Planning, Radiation Therapy Treatment
Monaco
| Applicant | Impac Medical Systems, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Jul 7, 2015 |
| Received | May 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2023 | Elekta Inc Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | None listed |
| Jul 3, 2019 | Elekta Inc Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Open, Classified |
MUJ | None listed |
| Jan 10, 2017 | Elekta, Inc. Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
| Dec 21, 2016 | Elekta, Inc. Monaco RTP System
Product Usage:
Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
| Nov 3, 2016 | Elekta, Inc. Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
| Sep 29, 2016 | Elekta, Inc. Monaco RTP System
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displ Terminated |
MUJ | None listed |
| May 18, 2016 | Elekta, Inc. Monaco RTP System
Product Usage:
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
| Oct 30, 2015 | Elekta, Inc. Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
| Oct 7, 2015 | Elekta, Inc. Monaco Radiation Treatment Planning System.
Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.