510(k) K082005 ยท MUJ System, Planning, Radiation Therapy Treatment
MODIFICATION TO HI-ART TREATMENT SYSTEM
| Applicant | Tomotherapy Incorporated, Madison WI, US |
| Decision | Substantially Equivalent, Aug 25, 2008 |
| Received | Jul 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Accuray Incorporated HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003.
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, ster Terminated |
MUJ | None listed |
| Jul 7, 2011 | Accuray Incorporated TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise deliv Terminated |
MUJ | None listed |
| Mar 14, 2011 | TomoTherapy Incorporated TomoTherapy Hi-ART System, Model # H-0000-0003
Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radio Terminated |
MUJ | None listed |
| Dec 27, 2010 | TomoTherapy Incorporated ThomoTherapy Hi-Art System
Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or Terminated |
MUJ | None listed |
| Aug 12, 2010 | TomoTherapy Incorporated Hi-Art System, H-0000-0003
Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, Terminated |
MUJ | None listed |
| Aug 2, 2010 | TomoTherapy Incorporated TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1.
TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717.
Intended to be used as an integrated system for planning and precise delivery of radi Terminated |
MUJ | None listed |
| Jul 22, 2010 | TomoTherapy Incorporated TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to be used as an integrated system for th Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.