510(k) · Cleared
ClearedAI-Rad Companion Organs RT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Oct 14, 2022 as substantially equivalent to K193562 (Siemens Medical Solutions USA, Inc., 2020) after a 162-day review. Its family tree reaches back 16 generations to 1996. 1 of the 108 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 14, 2022
- Review
- 162 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K954874 (1996). 102 ancestors in all, the oldest K885054 (1989). 5 later devices descend from it, 2 citing it directly. 1 of the 108 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 backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 1 generation backK193562 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020
- This deviceK221305 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK232899 AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A. · 2024
- Descendant · 2 generations on · 2 of its ownK242745 AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2025
- Descendant · 3 generations on · 0 of its ownK261306 AI Contouring (VA10A)Varian Medical Systems · 2026
- Descendant · 3 generations on · 0 of its ownK252548 AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2026
- Descendant · cites it directly · 0 of its ownK232928 DeepContour (V1.0)Wisdom Technologies., Inc. · 2024
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 backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 1 generation backK193562 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020
- This deviceK221305 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2022
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…6 generations back · 1999
Most influential descendants
Showing 5 of 5 · See all- K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A. · 2024 · cites it directly3descendants
- K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2025 · 2 generations on2descendants
- K261306AI Contouring (VA10A)Varian Medical Systems · 2026 · 3 generations on0descendants
- K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2026 · 3 generations on0descendants
- K232928DeepContour (V1.0)Wisdom Technologies., Inc. · 2024 · cites it directly0descendants
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 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| −1 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020 | — |
| 0 (this device) | K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +1 | K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | 2024 | — |
| +2 | K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2025 | — |
| +3 | K261306 | AI Contouring (VA10A) | Varian Medical Systems | 2026 | — |
| +3 | K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2026 | — |
| +1 | K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 1 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K193562 | AI-Rad Companion Organs RTSummary page 5…Device Product Name: AI-Rad Companion Organs RT Common Name: Medical Imaging Software 510(k) Number: K193562 Clearance Date: November 6, 2020 Classification Name: Picture Archiving and Communication Sy… | 2020 |
| † | K213976 | Contour ProtégéAI | 2022 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 6 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 31 of the 102 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232899 (Siemens Medical Solutions U.S.A., 2024) has gone furthest, with 3 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. 2022, 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?
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring…
Read the full statement (121 words)
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.
Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT.
The output of AI-Rad Companion Organs RT in the format of RTSTRUCT objects are intended to be used by trained medical professionals.
The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.
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/K221305 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221305: AI-Rad Companion Organs RT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221305
Report an extraction error
Are you the manufacturer?
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