510(k) K132971 ยท MUJ System, Planning, Radiation Therapy Treatment
MONACO
| Applicant | Impac Medical Systems, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Nov 20, 2013 |
| Received | Sep 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132971
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 17, 2016 | Elekta, Inc. Monaco TRP System
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. Terminated |
MUJ | None listed |
| Mar 2, 2015 | Elekta, Inc. Monaco radiation therapy treatment planning system.
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dos Terminated |
MUJ | None listed |
| Sep 4, 2014 | Elekta, Inc. Monaco
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and d Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.