510(k) · Cleared
ClearedContour ProtégéAI+
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 Mar 27, 2026 as substantially equivalent to K250035 (Mim Software, Inc., 2025) after a 179-day review. Its family tree reaches back 21 generations to 1996. 1 of the 169 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 27, 2026
- Review
- 179 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K954874 (1996). 168 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet. 1 of the 169 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 17 generations between
- 3 generations backK223774 Contour ProtégéAIMim Software, Inc. · 2023
- 2 generations backK231765 Contour ProtégéAIMim Software, Inc. · 2023
- 1 generation backK250035 Contour ProtégéAI+Mim Software, Inc. · 2025
- This deviceK253270 Contour ProtégéAI+Mim Software, Inc. · 2026
Show all 21 generations
- Root · 21 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 20 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 19 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 18 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 17 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 16 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 15 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 14 generations backK062163 MimviewerMimvista Corp. · 2006
- 13 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 12 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 11 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 10 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 9 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 8 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 7 generations backK190379 MIM on LinuxMim Software, Inc. · 2019
- 6 generations backK193252 Contour ProtegeAIMim Software, Inc. · 2020
- 5 generations backK210632 Contour ProtegeAIMim Software, Inc. · 2021
- 4 generations backK213976 Contour ProtégéAIMim Software, Inc. · 2022
- 3 generations backK223774 Contour ProtégéAIMim Software, Inc. · 2023
- 2 generations backK231765 Contour ProtégéAIMim Software, Inc. · 2023
- 1 generation backK250035 Contour ProtégéAI+Mim Software, Inc. · 2025
- This deviceK253270 Contour ProtégéAI+Mim Software, Inc. · 2026
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…10 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −20 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −19 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −18 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −17 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −16 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −15 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −14 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −13 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −12 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −11 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −10 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −9 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −8 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −7 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| −6 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | — |
| −5 | K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021 | — |
| −4 | K213976 | Contour ProtégéAI | Mim Software, Inc. | 2022 | — |
| −3 | K223774 | Contour ProtégéAI | Mim Software, Inc. | 2023 | — |
| −2 | K231765 | Contour ProtégéAI | Mim Software, Inc. | 2023 | — |
| −1 | K250035 | Contour ProtégéAI+ | Mim Software, Inc. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K250035 | Contour ProtégéAI+Summary page 5…System, Imaging Processing, Radiological Predicate and Reference Devices Predicate: K250035 Contour ProtégéAI+ MIM Software Inc. Reference: K071964 MIM 4.1 (SEASTAR) MIMvista Co… | 2025 |
| † | K071964 | Mim 4.1 (Seastar) | 2007 |
| † | K242729 | AutoContour (Model RADAC V4) | 2024 |
| † | K242925 | MR Contour DL | 2025 |
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 · 10 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 5 companies; a new generation was cleared every 1.2 years on median.
- 43 of the 168 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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, aiding image registration, transferring contours to…
Read the full statement (105 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, aiding image registration, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
Segmenting structures across a variety of CT and MR anatomical locations.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253270: Contour ProtégéAI+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253270
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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