510(k) · Cleared
ClearedAI-Rad Companion (Cardiovascular)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions U.S.A. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 6, 2023 as substantially equivalent to K183268 (Siemens Medical Solutions USA, Inc., 2019) after a 245-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Apr 6, 2023
- Review
- 245 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954678 (1996). 95 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet.
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations between
- 3 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 2 generations backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- 1 generation backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- This deviceK222360 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A. · 2023
Show all 11 generations
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 9 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 8 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 7 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 6 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 5 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 4 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 2 generations backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- 1 generation backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- This deviceK222360 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −10 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −9 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −8 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −7 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −6 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −5 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −4 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −2 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −1 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| 0 (this device) | K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions U.S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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.
Planning a device in JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K183268 | AI-Rad Companion (Cardiovascular)Summary page 5…: AI-Rad Companion (Cardiovascular) Propriety Trade Name: AI-Rad Companion (Cardiovascular) 510(k) Number: K183268 Clearance Date: September 10, 2019 Classification Name: System, X-Ray, Tomography, Compute… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 20 of the 95 ancestors have a recall of any class.
- 1 other device also cites its predicate K183268.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: - Segmentation and volume measurement of the heart - Quantification…
Read the full statement (142 words)
AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases.
It provides the following functionality:
- Segmentation and volume measurement of the heart
- Quantification of the total calcium volume in the coronary arteries
- Segmentation of the aorta
- Measurement of maximum diameters of the aorta at typical landmarks
- Threshold-based highlighting of enlarged diameters
The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers.
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/K222360 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222360: AI-Rad Companion (Cardiovascular).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222360
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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