510(k) K110730 ยท MUJ System, Planning, Radiation Therapy Treatment
MONACO RTP SYSTEM
| Applicant | Computerized Medical Systems, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Jun 24, 2011 |
| Received | Mar 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110730
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 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 25, 2013 | Elekta, Inc. Monaco RTP System
Radiation treatment planning Terminated |
MUJ | None listed |
| Sep 25, 2013 | Elekta, Inc. Monaco RTP System Radiation Therapy Treatment Planning System.
Radiation treatment planning. Terminated |
MUJ | None listed |
| Feb 20, 2013 | Elekta, Inc. Monaco RTP System.
Radiation treatment planning. Terminated |
MUJ | None listed |
| Jul 12, 2012 | Elekta, Inc. Monaco
Product Usage:
Planning of radiation therapy Terminated |
MUJ | None listed |
| Apr 3, 2012 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Version 3.10.00.
Planning of 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.