510(k) · Cleared
ClearedART.1-US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seetreat Pty, Ltd. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 14, 2026 as substantially equivalent to K232479 (Therapanacea, 2023) after a 233-day review. Its family tree reaches back 19 generations to 1996. 1 of the 226 devices in its family, counting itself, has a Class I recall.
- Decided
- May 14, 2026
- Review
- 233 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K954874 (1996). 225 ancestors in all, the oldest K864886 (1987). No later device cites it as a predicate yet. 1 of the 226 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 15 generations between
- 3 generations backK220813 Art-PlanTherapanacea · 2022
- 2 generations backK230023 ART-PlanTherapanacea Sas · 2023
- 1 generation backK232479 ART-PlanTherapanacea · 2023
- This deviceK253078 ART.1-USSeetreat Pty, Ltd. · 2026
Show all 19 generations
- Root · 19 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 18 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 17 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 16 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 15 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 14 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 13 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 12 generations backK062163 MimviewerMimvista Corp. · 2006
- 11 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 10 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 9 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 8 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 7 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 6 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 5 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 4 generations backK202700 ART-PlanTherapanacea · 2021
- 3 generations backK220813 Art-PlanTherapanacea · 2022
- 2 generations backK230023 ART-PlanTherapanacea Sas · 2023
- 1 generation backK232479 ART-PlanTherapanacea · 2023
- This deviceK253078 ART.1-USSeetreat Pty, Ltd. · 2026
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…9 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −18 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −17 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −16 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −15 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −14 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −13 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −12 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −11 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −10 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −9 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −8 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −7 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −6 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −5 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| −4 | K202700 | ART-Plan | Therapanacea | 2021 | — |
| −3 | K220813 | Art-Plan | Therapanacea | 2022 | — |
| −2 | K230023 | ART-Plan | Therapanacea Sas | 2023 | — |
| −1 | K232479 | ART-Plan | Therapanacea | 2023 | — |
| 0 (this device) | K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 1 |
| 2000 | 17 | 0 |
| 2001 | 17 | 0 |
| 2002 | 15 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K232479 | ART-PlanSummary page 7…MUJ Classification panel: Radiology 510(k) clearance: K232479 4.0 Summary of substantial equivalence Proposed device (ART.1-US) Predicate device (ART-Plan)… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 9 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 81 of the 225 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K232479.
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. 2026, 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?
ART.1-US is a software as a medical device intended to support the treatment re-plan process for cancer patients receiving radiation therapy.
ART.1-US calculates delivered dose and contours based on cancer patients’ daily volumetric images, in addition to displaying and reporting relevant metrics. ART.1-US allows for the comparison of dosimetry between the delivery of each fraction and the treatment plan in radiation oncology.
ART.1-US is intended for use by trained medical professionals as a decision support tool to aid the treatment re-plan process.
ART.1-US is indicated for adult Head & Neck cancer patients undergoing radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253078: ART.1-US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253078
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026