510(k) K052345 ยท KPQ System, Simulation, Radiation Therapy
ADVANTAGE SIM MD
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 14, 2005 |
| Received | Aug 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2013 | GE Healthcare, LLC AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Terminated |
KPQ | None listed |
| Mar 2, 2011 | GE Healthcare, LLC GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0
Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatme Terminated |
KPG | None listed |
| Aug 17, 2009 | GE Medical Systems, LLC AdvantageSim MD versions 7.4 through 7.6, Model 5160092.
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosime Terminated |
KPQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.