510(k) · Cleared
ClearedTomotherapy Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomotherapy Incorporated · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 7, 2011 as substantially equivalent to K082005 (Tomotherapy Incorporated, 2008) after a 44-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Oct 7, 2011
- Review
- 44 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K914698 (1992). 25 ancestors in all, the oldest K882729 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations between
- 3 generations backK042739 HI-Art SystemTomotherapy Incorporated · 2004
- 2 generations backK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
- 1 generation backK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- This deviceK112446 Tomotherapy Treatment SystemTomotherapy Incorporated · 2011
Show all 9 generations
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 8 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 7 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 6 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 5 generations backK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- 4 generations backK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- 3 generations backK042739 HI-Art SystemTomotherapy Incorporated · 2004
- 2 generations backK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
- 1 generation backK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- This deviceK112446 Tomotherapy Treatment SystemTomotherapy Incorporated · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −8 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −7 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −6 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −5 | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| −4 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| −3 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| −2 | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | 4 |
| −1 | K082005 | Modification to HI-Art Treatment System | Tomotherapy Incorporated | 2008 | 7 |
| 0 (this device) | K112446 | Tomotherapy Treatment System | Tomotherapy Incorporated | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082005 | Modification to HI-Art Treatment SystemSummary page 1…: 21 CFR 892.5050 Regulation Description: Medical charged particle radiation therapy system Predicate Device: TomoThcrapy I-i-Art System (modified) K082005 Description: The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calcula… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K082005.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The TomoTherapy Treatment System is 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 other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician prescribed and approved plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112446: Tomotherapy Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112446
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026