510(k) · Cleared
ClearedHI-Art System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomo Therapy, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 28, 2002 as substantially equivalent to K002237 (Adac Laboratories, 2001) and 5 other predicates after an 83-day review. Its family tree reaches back 4 generations to 1992. 27 later devices descend from it.
- Decided
- Jan 28, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K914698 (1992). 19 ancestors in all, the oldest K882729 (1988). 27 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 2 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 1 generation backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- This deviceK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- Descendant · cites it directly · 26 of its ownK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- Descendant · 2 generations on · 25 of its ownK042739 HI-Art SystemTomotherapy Incorporated · 2004
- Descendant · 3 generations on · 24 of its ownK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
- Descendant · 4 generations on · 13 of its ownK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- Descendant · 5 generations on · 11 of its ownK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K033347Modification to: HI-Art SystemTomotherapy Incorporated · 2003 · cites it directly26descendants
- K042739HI-Art SystemTomotherapy Incorporated · 2004 · 2 generations on25descendants
- K060912Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · 3 generations on24descendants
- K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · 4 generations on13descendants
- K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −3 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −2 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −1 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| 0 (this device) | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| +1 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| +2 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| +3 | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | 4 |
| +4 | K082005 | Modification to HI-Art Treatment System | Tomotherapy Incorporated | 2008 | 7 |
| +5 | K112776 | Tomotherapy Treatment System Fast Optimizer | 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 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 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? (6)
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 |
|---|---|---|---|
| * | K002237 | P3IMRT TMSummary page 1…3562 (608) 824-0995 (608) 824-0996 November 3, 2001 HI-ART System Radiation Therapy System Medical Charged Particle Radiation Therapy System ADAC P3IMRT & Pinnacle 3 K002237 & K993923 Marconi AcQSim CT K923851 GE 3D Advantage Windows Fusion K983256 Marconi AcQSim Fusion K003437 Siemens Genesis IMRT… | 2001 |
| * | K993923 | Adac PINNACLE3TM Radiation Therapy Planning SystemSummary page 1…) 824-0995 (608) 824-0996 November 3, 2001 HI-ART System Radiation Therapy System Medical Charged Particle Radiation Therapy System ADAC P3IMRT & Pinnacle 3 K002237 & K993923 Marconi AcQSim CT K923851 GE 3D Advantage Windows Fusion K983256 Marconi AcQSim Fusion K003437 Siemens Genesis IMRT K982502… | 2000 |
| * | K923851 | Acqsim Simulator/LocalizerSummary page 1…November 3, 2001 HI-ART System Radiation Therapy System Medical Charged Particle Radiation Therapy System ADAC P3IMRT & Pinnacle 3 K002237 & K993923 Marconi AcQSim CT K923851 GE 3D Advantage Windows Fusion K983256 Marconi AcQSim Fusion K003437 Siemens Genesis IMRT K982502 The TomoTherapy HI-ART Syst… | 1992 |
| * | K983256 | Advantage Windows (AW) FusionSummary page 1…Therapy System Medical Charged Particle Radiation Therapy System ADAC P3IMRT & Pinnacle 3 K002237 & K993923 Marconi AcQSim CT K923851 GE 3D Advantage Windows Fusion K983256 Marconi AcQSim Fusion K003437 Siemens Genesis IMRT K982502 The TomoTherapy HI-ART System is intended to be used as an integrat… | 1998 |
| * | K003437 | Odyssey LX, Model 211320Summary page 1…d Particle Radiation Therapy System ADAC P3IMRT & Pinnacle 3 K002237 & K993923 Marconi AcQSim CT K923851 GE 3D Advantage Windows Fusion K983256 Marconi AcQSim Fusion K003437 Siemens Genesis IMRT K982502 The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and… | 2001 |
| * | K982502 | Genesis Imrt Linear AcceleratorSummary page 1…ystem ADAC P3IMRT & Pinnacle 3 K002237 & K993923 Marconi AcQSim CT K923851 GE 3D Advantage Windows Fusion K983256 Marconi AcQSim Fusion K003437 Siemens Genesis IMRT K982502 The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulate… | 1998 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033347 | Modification to: HI-Art System | 2003 | 26 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K033347 (Tomotherapy Incorporated, 2003) has gone furthest, with 26 descendants of its own.
- 4 other devices also cite its predicate K002237.
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.
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 delivery of intensity modulated radiation therapy (IMRT) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue. The HI-ART System’s planning station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a…
Read the full statement (214 words)
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue.
The HI-ART System’s planning 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 HI-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 an MVCT scan (a CT using the onboard linear accelerator as the radiation source). This MVCT image will confirm that the patient’s position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The MVCT image is not for diagnostic use.
When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy treatment in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013673: HI-Art System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013673
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026