510(k) Report

FDA applicant

Tomotherapy Incorporated

Madison, WI6 decisions2003–201111 recalls

FDA records 6 decisions for Tomotherapy Incorporated (Madison, WI) from 2003 to 2011: 6 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IYE (Accelerator, Linear, Medical). Its devices cite 7 predicates, 5 of them its own earlier devices. 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Tomotherapy Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2008: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2011

2008: 32009: 22010: 32011: 3
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tomotherapy Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tomotherapy Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment4decisions
  • IYEAccelerator, Linear, Medical2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 20082cite it
  • K060912Modification to: HI-Art SystemTomotherapy Incorporated · 20062cite it
  • K042739HI-Art SystemTomotherapy Incorporated · 20041cites it
  • K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 20111cites it
  • K033347Modification to: HI-Art SystemTomotherapy Incorporated · 20031cites it

What has FDA decided for it lately?

  • K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
  • K112446Tomotherapy Treatment SystemTomotherapy Incorporated · 2011
  • K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 20087 recalls
  • K060912Modification to: HI-Art SystemTomotherapy Incorporated · 20064 recalls
  • K042739HI-Art SystemTomotherapy Incorporated · 2004
  • K033347Modification to: HI-Art SystemTomotherapy Incorporated · 2003

All 6 as Tomotherapy Incorporated →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K082005HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System…Jul 13, 2011
  • K082005TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717…Jul 7, 2011
  • K082005TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated…Jan 26, 2011
  • K082005ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning…Nov 8, 2010
  • K082005TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240…Jun 23, 2010
  • K082005TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming…Feb 22, 2010