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 Healthcare GmbH · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Apr 10, 2026 as substantially equivalent to K242745 (Siemens Healthcare GmbH, 2025) after a 240-day review. Its family tree reaches back 19 generations to 1996. 1 of the 106 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 10, 2026
- Review
- 240 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K954874 (1996). 105 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 1 of the 106 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 15 generations between
- 3 generations backK221305 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2022
- 2 generations backK232899 AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A. · 2024
- 1 generation backK242745 AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2025
- This deviceK252548 AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2026
Show all 19 generations
- Root · 19 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 18 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 17 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 16 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 15 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 14 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 13 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 12 generations backK062163 MimviewerMimvista Corp. · 2006
- 11 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 10 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 9 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 8 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 7 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 6 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 5 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 4 generations backK193562 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020
- 3 generations backK221305 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2022
- 2 generations backK232899 AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A. · 2024
- 1 generation backK242745 AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2025
- This deviceK252548 AI-Rad Companion Organs RTSiemens Healthcare GmbH · 2026
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…9 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −18 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −17 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −16 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −15 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −14 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −13 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −12 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −11 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −10 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −9 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −8 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −7 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −6 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −5 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| −4 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −3 | K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2022 | — |
| −2 | K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | 2024 | — |
| −1 | K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2025 | — |
| 0 (this device) | K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K242745 | AI-Rad Companion Organs RTSummary page 6…QKB 4. Predicate Device Product Name: AI-Rad Companion Organs RT Common Name: Medical Imaging Software 510(k) Number: K242745 Clearance Date: March 27, 2025 Classification Name: Medical Image Management and Processing System Classific… | 2025 |
| † | K230685 | AutoContour Model RADAC V3 | 2023 |
| † | K232899 | AI-Rad Companion Organs RT | 2024 |
| † | K203235 | VBrain | 2021 |
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 · 9 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 9 companies; a new generation was cleared every 1.3 years on median.
- 31 of the 105 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K242745.
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?
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures, including known (diagnosed) brain metastases, using deep-learning-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as…
Read the full statement (110 words)
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures, including known (diagnosed) brain metastases, using deep-learning-based algorithms.
Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including 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 outputs of AI-Rad Companion Organs RT are intended to be used by qualified and trained medical professionals.
The software is not intended to be used for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252548: AI-Rad Companion Organs RT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252548
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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