510(k) K121934 ยท IYE Accelerator, Linear, Medical
TOMOTHERAPY TREATMENT SYSTEM
| Applicant | Accuray Incorporated, Madison WI, US |
| Decision | Substantially Equivalent, Aug 29, 2012 |
| Received | Jul 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2020 | Accuray Incorporated TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors Terminated |
IYE | None listed |
| Nov 17, 2017 | Accuray Incorporated Hi-Art(R) System, Model Number H-000-0003
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, s Terminated |
IYE | None listed |
| Nov 17, 2017 | Accuray Incorporated TomoHD(R) System, Model Number 1018283
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, ster Terminated |
IYE | None listed |
| Nov 17, 2017 | Accuray Incorporated TomoH(R) System, Model Number 1018284
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stere Terminated |
IYE | None listed |
| Nov 17, 2017 | Accuray Incorporated TomoHDA(R) System, Model Number 1018286
Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, ste Terminated |
IYE | None listed |
| Dec 12, 2014 | TomoTherapy Incorporated TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Terminated |
IYE | None listed |
| Aug 15, 2014 | TomoTherapy Incorporated TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2).
. Terminated |
IYE | None listed |
| Aug 15, 2014 | TomoTherapy Incorporated TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1).
The TomoTherapy treatment system is intended to be used as Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.