510(k) · Cleared
ClearedContour ProtegeAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mim Software, Inc. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Oct 20, 2021 as substantially equivalent to K193252 (Mim Software, Inc., 2020) after a 231-day review. Its family tree reaches back 16 generations to 1996. 1 of the 169 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 20, 2021
- Review
- 231 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K954874 (1996). 163 ancestors in all, the oldest K871859 (1987). 5 later devices descend from it, 1 citing it directly. 1 of the 169 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations between
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK190379 MIM on LinuxMim Software, Inc. · 2019
- 1 generation backK193252 Contour ProtegeAIMim Software, Inc. · 2020
- This deviceK210632 Contour ProtegeAIMim Software, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK213976 Contour ProtégéAIMim Software, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK223774 Contour ProtégéAIMim Software, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK231765 Contour ProtégéAIMim Software, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK250035 Contour ProtégéAI+Mim Software, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK253270 Contour ProtégéAI+Mim Software, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 15 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 14 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 13 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 12 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 11 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 10 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 9 generations backK062163 MimviewerMimvista Corp. · 2006
- 8 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 7 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 6 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 5 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 4 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK190379 MIM on LinuxMim Software, Inc. · 2019
- 1 generation backK193252 Contour ProtegeAIMim Software, Inc. · 2020
- This deviceK210632 Contour ProtegeAIMim Software, Inc. · 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- K213976Contour ProtégéAIMim Software, Inc. · 2022 · cites it directly4descendants
- K223774Contour ProtégéAIMim Software, Inc. · 2023 · 2 generations on3descendants
- K231765Contour ProtégéAIMim Software, Inc. · 2023 · 3 generations on2descendants
- K250035Contour ProtégéAI+Mim Software, Inc. · 2025 · 4 generations on1descendant
- K253270Contour ProtégéAI+Mim Software, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −15 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −14 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −13 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −12 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −11 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −10 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −9 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −8 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −7 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −5 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −2 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| −1 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | — |
| 0 (this device) | K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021 | — |
| +1 | K213976 | Contour ProtégéAI | Mim Software, Inc. | 2022 | — |
| +2 | K223774 | Contour ProtégéAI | Mim Software, Inc. | 2023 | — |
| +3 | K231765 | Contour ProtégéAI | Mim Software, Inc. | 2023 | — |
| +4 | K250035 | Contour ProtégéAI+ | Mim Software, Inc. | 2025 | — |
| +5 | K253270 | Contour ProtégéAI+ | Mim Software, Inc. | 2026 | — |
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 |
| 2025 | 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.
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 |
|---|---|---|---|
| K213976 | Contour ProtégéAI | 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 5 companies; a new generation was cleared every 1.3 years on median.
- 43 of the 163 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K213976 (Mim Software, Inc., 2022) has gone furthest, with 4 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. 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?
Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment…
Read the full statement (116 words)
Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications:
Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
Segmenting normal structures across a variety of CT anatomical locations.
And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210632: Contour ProtegeAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210632
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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