510(k) · Cleared
Recalled · 2009Modification to: HI-Art System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomotherapy Incorporated · IYE Accelerator, Linear, Medical
Cleared on Apr 19, 2006 as substantially equivalent to K042739 (Tomotherapy Incorporated, 2004) after a 16-day review. Its family tree reaches back 7 generations to 1992. 24 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 19, 2006
- Review
- 16 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914698 (1992). 22 ancestors in all, the oldest K882729 (1988). 24 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 5 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 4 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 3 generations backK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- 2 generations backK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- 1 generation backK042739 HI-Art SystemTomotherapy Incorporated · 2004
- This deviceK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006
- Descendant · cites it directly · 13 of its ownK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- Descendant · 2 generations on · 11 of its ownK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
- Descendant · 3 generations on · 10 of its ownK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
- Descendant · cites it directly · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · cites it directly13descendants
- K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011 · 2 generations on11descendants
- K121934Tomotherapy Treatment SystemAccuray Incorporated · 2012 · 3 generations on10descendants
- K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · cites it directly9descendants
- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −6 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −5 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −4 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −3 | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| −2 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| −1 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| 0 (this device) | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | — |
| +1 | K082005 | Modification to HI-Art Treatment System | Tomotherapy Incorporated | 2008 | 7 |
| +2 | K112776 | Tomotherapy Treatment System Fast Optimizer | Tomotherapy Incorporated | 2011 | — |
| +3 | K121934 | Tomotherapy Treatment System | Accuray Incorporated | 2012 | 8 |
| +1 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
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 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K042739 | HI-Art SystemSummary page 1…System Predicate Device: TomoTherapy Hi-Art System K042739 INTENDED USE The TomoTherapy HI-ART System" is intended to be used as an integrated system for the planning an… | 2004 |
What descends from it? (24)
See all 242 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 |
|---|---|---|---|---|
| Aug 10, 2009 | Not classified | Z-2243-2009 | Software design | TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station… |
| Oct 14, 2008 | Not classified | Z-0628-2009 | Software design | TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access… |
| Sep 18, 2008 | Not classified | Z-0339-2009 | Software design | TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit… |
| Feb 22, 2008 | Not classified | Z-1615-2008 | Software design | Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will move the couch to the correct offset… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K082005 (Tomotherapy Incorporated, 2008) has gone furthest, with 13 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The TomoTherapy 11I-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy…
Read the full statement (220 words)
The TomoTherapy 11I-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.
The [II-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomolmageTM (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This Tomolmage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The Tomohnage (MVCT image) is not for diagnostic use.
When patient positioning is complete, the 1ll-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The l1-ART System delivers the radiation therapy treatment, stereotactic radiotherapy, or stereotactic radiosurgery in accordance with the physician approved plan delivered in a helical tomographic pattern.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060912 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060912: Modification to: HI-Art System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060912
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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