510(k) · Cleared
ClearedAI-Rad Companion Engine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 10, 2020 as substantially equivalent to K183272 (Siemens Medical Solutions USA, Inc., 2019) after a 226-day review. Its family tree reaches back 14 generations to 1991. 3 of the 185 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 10, 2020
- Review
- 226 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 184 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 185 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK150843 syngo®.via (version VB10A)Siemens AG · 2015
- 2 generations backK170952 syngo.CT View&GOSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK183272 AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc. · 2019
- This deviceK193294 AI-Rad Companion EngineSiemens Medical Solutions USA, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 12 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 11 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 10 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 9 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 7 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 5 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 4 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 3 generations backK150843 syngo®.via (version VB10A)Siemens AG · 2015
- 2 generations backK170952 syngo.CT View&GOSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK183272 AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc. · 2019
- This deviceK193294 AI-Rad Companion EngineSiemens Medical Solutions USA, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −12 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −11 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −10 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −9 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −7 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −5 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −3 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| −2 | K170952 | syngo.CT View&GO | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −1 | K183272 | AI Rad Companion (Engine) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| 0 (this device) | K193294 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 13 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 1 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 3 | 1 |
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.
3 devices in this family have 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K183272 | AI Rad Companion (Engine)Summary page 5…Device Product Name: AI-Rad Companion (Engine) Propriety Trade Name: AI-Rad Companion (Engine) 510(k) Number: K183272 Clearance Date: February 1, 2019 Classification Name: Picture Archiving and Communication Sy… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 5 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 7 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 184 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K183272.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Al-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides the means for viewing, storing and transferring data into other systems such as PACS systems.…
Read the full statement (135 words)
Al-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes.
The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides the means for viewing, storing and transferring data into other systems such as PACS systems.
The software platform also provides an interface to integrate additional Siemens Healthineers' clinical processing extensions.
Al-Rad Companion Engine functionality includes:
- Interface for multi-modality and multi-vendor Input/Output of DICOM data
- Check of data validity using information of DICOM tags
- Interface for extensions that provide post-processing functionality
- Confirmation user interface for visualization of medical images processed by extensions
- Configuration user interface for configuration of the medical device and extensions
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/K193294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193294: AI-Rad Companion Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193294
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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