510(k) K091179 ยท MUJ System, Planning, Radiation Therapy Treatment
MONACO RTP SYSTEM, VMAT OPTION
| Applicant | Computerized Medical Systems, Inc., Maryland Heights MO, US |
| Decision | Substantially Equivalent, Jul 16, 2009 |
| Received | Apr 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091179
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above
To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) h Terminated |
MUJ | None listed |
| Jun 15, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above.
Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy ( Terminated |
MUJ | None listed |
| Jun 14, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.
The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity mo Terminated |
MUJ | None listed |
| Jun 14, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2.
Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMR Terminated |
MUJ | None listed |
| Jun 14, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above
Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.