510(k) · Cleared
ClearedART-Plan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therapanacea · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Jan 14, 2021 as substantially equivalent to K191928 (Xiamen Manteia Technology, Ltd., 2020) and 3 other predicates after a 120-day review. Its family tree reaches back 15 generations to 1996. 1 of the 168 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jan 14, 2021
- Review
- 120 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K954874 (1996). 162 ancestors in all, the oldest K871859 (1987). 5 later devices descend from it, 1 citing it directly. 1 of the 168 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations between
- 3 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 2 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 1 generation backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- This deviceK202700 ART-PlanTherapanacea · 2021
- Descendant · cites it directly · 4 of its ownK220813 Art-PlanTherapanacea · 2022
- Descendant · 2 generations on · 3 of its ownK230023 ART-PlanTherapanacea Sas · 2023
- Descendant · 3 generations on · 2 of its ownK232479 ART-PlanTherapanacea · 2023
- Descendant · 4 generations on · 0 of its ownK253078 ART.1-USSeetreat Pty, Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK234068 ART-Plan (v.2.2.0)Therapanacea Sas · 2024
Show all 15 generations
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 14 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 13 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 12 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 11 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 10 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 9 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 8 generations backK062163 MimviewerMimvista Corp. · 2006
- 7 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 6 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 5 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 4 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 3 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 2 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 1 generation backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- This deviceK202700 ART-PlanTherapanacea · 2021
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…5 generations back · 1999
Most influential descendants
Showing 5 of 5 · See all- K220813Art-PlanTherapanacea · 2022 · cites it directly4descendants
- K230023ART-PlanTherapanacea Sas · 2023 · 2 generations on3descendants
- K232479ART-PlanTherapanacea · 2023 · 3 generations on2descendants
- K253078ART.1-USSeetreat Pty, Ltd. · 2026 · 4 generations on0descendants
- K234068ART-Plan (v.2.2.0)Therapanacea Sas · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −14 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −13 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −12 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −11 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −10 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −9 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −8 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −7 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −4 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −3 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −2 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −1 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| 0 (this device) | K202700 | ART-Plan | Therapanacea | 2021 | — |
| +1 | K220813 | Art-Plan | Therapanacea | 2022 | — |
| +2 | K230023 | ART-Plan | Therapanacea Sas | 2023 | — |
| +3 | K232479 | ART-Plan | Therapanacea | 2023 | — |
| +4 | K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026 | — |
| +4 | K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 1 |
| 2000 | 14 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 QKB device
- #1 K191928 AccuContourscore 32.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K191928 | AccuContourSummary page 6…/A Manufacturer Technology LTD Inc) 510k N/A K191928 K130393 K181572 K071964 N/A Device… | 2020 |
| * | K130393 | Mirada RTXSummary page 6…Technology LTD Inc) 510k N/A K191928 K130393 K181572 K071964 N/A Device II… | 2013 |
| * | K181572 | Workflow BoxSummary page 6…chnology LTD Inc) 510k N/A K191928 K130393 K181572 K071964 N/A Device II II… | 2018 |
| * | K071964 | Mim 4.1 (Seastar)Summary page 6…Inc) 510k N/A K191928 K130393 K181572 K071964 N/A Device II II II II… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220813 | Art-Plan | 2022 | 4 |
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 · 5 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 43 of the 162 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220813 (Therapanacea, 2022) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K191928.
How does its category compare?
All QKB devicesQKB Radiological Image Processing Software For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QKB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKB
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKB
No recall names QKB since 2007.
Adverse event reports per year · QKB
No MAUDE report names QKB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | 244 | 0 | 0 |
| 2021 | 9 | 120 | 0 | 0 |
| 2022 | 7 | 162 | 0 | 0 |
| 2023 | 7 | 111 | 0 | 0 |
| 2024 | 6 | 173 | 0 | 0 |
| 2025 | 6 | 170 | 0 | 0 |
| 2026 | 9 | 179 | 0 | — |
What is it indicated for?
ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned. The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registration…
Read the full statement (171 words)
ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.
The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.
The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images.
The contours created automatically, semi-automatically or manually require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
The device is intended to be used in a clinical setting, by trained professionals only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202700: ART-Plan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202700
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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