510(k) · Cleared
ClearedART-Plan (v.2.2.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therapanacea Sas · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 22, 2024 as substantially equivalent to K232479 (Therapanacea, 2023) after a 122-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
- Apr 22, 2024
- Review
- 122 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 deviceK234068 ART-Plan (v.2.2.0)Therapanacea Sas · 2024
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 deviceK234068 ART-Plan (v.2.2.0)Therapanacea Sas · 2024
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) | K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | 2024 | — |
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 4…Number: 892.5050 Product Code: MUJ Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232479 ART-Plan MUJ Device Description Summary ART-Plan is a soft… | 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 28 years and passes through 8 companies; a new generation was cleared every 1.2 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. 2024, 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-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available.
ART-Plan is not intended to be used for patients less than 18 years of age.
The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process.
The indicated use environments are, but not limited to, hospitals, clinics and any health facility involved in radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234068: ART-Plan (v.2.2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234068
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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