510(k) · Cleared
Recalled · 2011Modification to HI-Art 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 Aug 25, 2008 as substantially equivalent to K060912 (Tomotherapy Incorporated, 2006) and 1 other predicate after a 42-day review. Its family tree reaches back 8 generations to 1992. 13 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 25, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 8 generations to K914698 (1992). 24 ancestors in all, the oldest K882729 (1988). 13 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 7 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 6 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 5 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 4 generations backK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- 3 generations backK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- 2 generations backK042739 HI-Art SystemTomotherapy Incorporated · 2004
- 1 generation backK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
- This deviceK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008
- Descendant · cites it directly · 11 of its ownK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
- Descendant · 2 generations on · 10 of its ownK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK161146 Radixact Treatment Delivery SystemAccuray Incorporated · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK161136 Precision Treatment Planning SystemAccuray Incorporated · 2016
- Descendant · 4 generations on · 1 of its ownK202412 ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011 · cites it directly11descendants
- K121934Tomotherapy Treatment SystemAccuray Incorporated · 2012 · 2 generations on10descendants
- K161146Radixact Treatment Delivery SystemAccuray Incorporated · 2016 · 3 generations on3descendants
- K161136Precision Treatment Planning SystemAccuray Incorporated · 2016 · 3 generations on2descendants
- K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −7 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −6 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −5 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −4 | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| −3 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| −2 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| −1 | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | 4 |
| 0 (this device) | K082005 | Modification to HI-Art Treatment System | Tomotherapy Incorporated | 2008 | — |
| +1 | K112776 | Tomotherapy Treatment System Fast Optimizer | Tomotherapy Incorporated | 2011 | — |
| +2 | K121934 | Tomotherapy Treatment System | Accuray Incorporated | 2012 | 8 |
| +3 | K161146 | Radixact Treatment Delivery System | Accuray Incorporated | 2016 | 1 |
| +3 | K161136 | Precision Treatment Planning System | Accuray Incorporated | 2016 | — |
| +4 | K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | Accuray Incorporated | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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 18.7 · 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? (2)
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 |
|---|---|---|---|
| * | K060912 | Modification to: HI-Art SystemSummary page 1…System Predicate Devices: TomoTherapy Hi-Art System K060912 Varian Clinac 600 K926321… | 2006 |
| * | K926321 | Varian C/D-Series Clinacs (Clinac 600 C/D)Summary page 1…K060912 Varian Clinac 600 K926321 4.2 Intended Use The TomoTherapy HI-ART System is intended to be used as an integrated system for the p… | 1994 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2011 | Not classified | Z-3108-2011 | Software design | As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported… |
| Jul 7, 2011 | Not classified | Z-3163-2011 | Device Design | TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting to open the TomoMobile shielding doors… |
| Jan 26, 2011 | Not classified | Z-1649-2011 | Software design | It was determined that the Treatment Planning Station (TPS) can potentially under dose. |
| Nov 8, 2010 | Not classified | Z-0814-2011 | Software design | TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure. |
| Jun 23, 2010 | Not classified | Z-2072-2010 | Software design | An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics. |
| Feb 22, 2010 | Not classified | Z-2115-2010 | Software design | In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. |
| Dec 1, 2009 | Not classified | Z-2219-2010 | Software design | An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K112776 (Tomotherapy Incorporated, 2011) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K060912.
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. 2008, 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 HI-ART 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 approved plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082005 · printed Nov 3, 2026
Cite this page
510(k) Report. “K082005: Modification to HI-Art Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082005
Report an extraction error
Are you the manufacturer?
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