510(k) · Cleared
ClearedART-Plan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therapanacea Sas · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Apr 19, 2023 as substantially equivalent to K220813 (Therapanacea, 2022) after a 105-day review. Its family tree reaches back 17 generations to 1996. 1 of the 168 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 19, 2023
- Review
- 105 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K954874 (1996). 164 ancestors in all, the oldest K871859 (1987). 3 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 · 17 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 13 generations between
- 3 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 2 generations backK202700 ART-PlanTherapanacea · 2021
- 1 generation backK220813 Art-PlanTherapanacea · 2022
- This deviceK230023 ART-PlanTherapanacea Sas · 2023
- Descendant · cites it directly · 2 of its ownK232479 ART-PlanTherapanacea · 2023
- Descendant · 2 generations on · 0 of its ownK253078 ART.1-USSeetreat Pty, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK234068 ART-Plan (v.2.2.0)Therapanacea Sas · 2024
Show all 17 generations
- Root · 17 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 16 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 15 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 14 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 13 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 12 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 11 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 10 generations backK062163 MimviewerMimvista Corp. · 2006
- 9 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 8 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 7 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 6 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 5 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 4 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 3 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 2 generations backK202700 ART-PlanTherapanacea · 2021
- 1 generation backK220813 Art-PlanTherapanacea · 2022
- This deviceK230023 ART-PlanTherapanacea Sas · 2023
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…7 generations back · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −16 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −15 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −14 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −13 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −12 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −11 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −10 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −9 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −8 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −7 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −6 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −5 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −4 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −3 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| −2 | K202700 | ART-Plan | Therapanacea | 2021 | — |
| −1 | K220813 | Art-Plan | Therapanacea | 2022 | — |
| 0 (this device) | K230023 | ART-Plan | Therapanacea Sas | 2023 | — |
| +1 | K232479 | ART-Plan | Therapanacea | 2023 | — |
| +2 | K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K220813 | Art-PlanSummary page 5…ion 510(k) Number Code TheraPanacea ART-Plan QKB 892.2050 K220813 SAS Submission Description This Special 510(k) covers a modification to add 48 new structures to existing localizations… | 2022 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232479 | ART-Plan | 2023 | 2 |
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 · 7 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 43 of the 164 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232479 (Therapanacea, 2023) has gone furthest, with 2 descendants of its own.
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. 2023, 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 indicated for cancer patients for whom radiation treatment has been planned. It is intended to be used by trained medical professionals including, but not limited to, radiologists, radiation oncologists, dosimetrists, and medical physicists. ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may mport, define, display, transform and store DICOM3.0 compliant datasets (including…
Read the full statement (174 words)
ART-Plan is indicated for cancer patients for whom radiation treatment has been planned. It is intended to be used by trained medical professionals including, but not limited to, radiologists, radiation oncologists, dosimetrists, and medical physicists.
ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may mport, define, display, transform and store DICOM3.0 compliant datasets (including regions of interest structures). These images, contours and objects can subsequently be exported/distributed within the system, across computer networks and/or to radiation treatment planning systems. Supported modalities include CT, PET-CT, CBCT, 4D-CT and MR images.
ART-Plan supports AI-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation.
To help the user assess changes in image data and to obtain combined multi-modal image information, ART-Plan allows the registration of anatomical and functional images and display of fused and non-fused images to facilitate the comparison of patient image data by the user.
With ART-Plan, users are also able to generate, visualize, evaluate and modify pseudo-CT from MRI images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230023: 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/K230023
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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