510(k) K013112 ยท MUJ System, Planning, Radiation Therapy Treatment
FOCAL SIM
| Applicant | Computerized Medical Systems, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 5, 2001 |
| Received | Sep 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2015 | Elekta, Inc. Focal Sim radiation therapy treatment planning system Terminated |
MUJ | None listed |
| Sep 3, 2014 | Elekta, Inc. FOCAL Sim Workstation, Radiation Treatment Planning System.
Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to t Terminated |
MUJ | None listed |
| Jul 12, 2012 | Elekta, Inc. Focal SIM
Planning of radiation therapy Terminated |
MUJ | None listed |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00.
Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal softwar Terminated |
MUJ | None listed |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above.
Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software a Terminated |
MUJ | None listed |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01
For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to Terminated |
MUJ | None listed |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above
for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to acc Terminated |
MUJ | None listed |
| Jun 15, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02.
For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users Terminated |
MUJ | None listed |
| Jun 14, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above.
Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability t Terminated |
MUJ | None listed |
| Jun 14, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00.
For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.