510(k) K060912 ยท IYE Accelerator, Linear, Medical
MODIFICATION TO: HI-ART SYSTEM
| Applicant | Tomotherapy Incorporated, Madison WI, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Apr 3, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2009 | TomoTherapy Incorporated TomoTherapy Hi-Art System, Version 3.X
ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717.
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and Terminated |
MUJ | None listed |
| Jan 22, 2009 | TomoTherapy Incorporated TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal.
TomoThera Terminated |
IYE | None listed |
| Jan 5, 2009 | TomoTherapy Incorporated TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended f Terminated |
IYE | None listed |
| Aug 24, 2008 | TomoTherapy Incorporated TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulate Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.