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 USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 10, 2019 as substantially equivalent to K990426 (Siemens Medical Solutions USA, Inc., 1999) and 2 other predicates after a 291-day review. Its family tree reaches back 10 generations to 1996. 11 later devices descend from it.
- Decided
- Sep 10, 2019
- Review
- 291 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K954678 (1996). 94 ancestors in all, the oldest K837107 (1983). 11 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 1 generation backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- This deviceK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · cites it directly · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · 2 generations on · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK243229 Bunkerhill AVCBunkerHill Health · 2025
- Descendant · 3 generations on · 0 of its ownK260166 Bunkerhill Contrast CACBunkerHill Health · 2026
- Descendant · 4 generations on · 0 of its ownK260167 Bunkerhill Contrast AVCBunkerHill Health · 2026
Show all 10 generations
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 8 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 7 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 6 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 5 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 4 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 3 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 1 generation backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- This deviceK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · cites it directly9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 2 generations on6descendants
- K243229Bunkerhill AVCBunkerHill Health · 2025 · 3 generations on3descendants
- K260166Bunkerhill Contrast CACBunkerHill Health · 2026 · 3 generations on0descendants
- K260167Bunkerhill Contrast AVCBunkerHill Health · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −9 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −8 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −7 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −6 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −5 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −4 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −3 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −1 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +1 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +2 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +3 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
| +3 | K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026 | — |
| +4 | K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K990426 | Calcium ScoringSummary page 4…roduct Code: LLZ III. Predicate Device Primary Predicate Device: Product/Proprietary Trade Name: syngo.CT Calcium Scoring 510(k) Number: K990426 Clearance Date: 05/12/1999 Classification Name: Computed Tomography X-Ray System Classification… | 1999 |
| * | K123585 | Syngo, CT Cardiac FunctionSummary page 4…ere are currently no recalls for this device Secondary Predicate Device: Product/Proprietary Trade Name: syngo.CT Cardiac Function 510(k) Number: K123585 Clearance Date: 12/20/2012 Classification Name: Computed Tomography X-Ray System Classification… | 2012 |
| * | K113027 | Syngo Aortic Valveguide SoftwareSummary page 5…are currently no recalls for this device Secondary Predicate Device: Product/Proprietary Trade Name: syngo aortic Valve Guide 510(k) Number: K113027 Clearance Date: 11/22/2011 Classification Name: Interventional Fluoroscopic X-Ray System Cla… | 2011 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 20 of the 94 ancestors have a recall of any class.
- Of its descendants, K210085 (Zebra Medical Vision, Ltd., 2021) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K990426.
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. 2019, 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 as stated in the FDA summary.
https://510kreport.com/device/K183268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183268: AI-Rad Companion (Cardiovascular).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183268
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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