510(k) · Cleared
ClearedCAC Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imbio, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 13, 2023 as substantially equivalent to K210085 (Zebra Medical Vision, Ltd., 2021) after a 147-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Jun 13, 2023
- Review
- 147 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954678 (1996). 103 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet.
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations between
- 3 generations backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- 2 generations backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- 1 generation backK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- This deviceK230112 CAC SoftwareImbio, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 11 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 10 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 9 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 8 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 7 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 6 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 5 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 3 generations backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- 2 generations backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- 1 generation backK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- This deviceK230112 CAC SoftwareImbio, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −11 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −10 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −9 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −8 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −7 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −6 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −5 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −3 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −2 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −1 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| 0 (this device) | K230112 | CAC Software | Imbio, Inc. | 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 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K210085 | HealthCCSngSummary page 4…Marketed Device To Which The Device Is Substantially Equivalent The CAC Software is substantially equivalent to the Zebra Medical Vision HealthCCSng cleared under K210085. 1 1.7 Description of the Device The Imbio CAC Software is… | 2021 |
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 10 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 103 ancestors have a recall of any class.
- 3 other devices also cite its predicate K210085.
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?
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary…
Read the full statement (156 words)
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230112: CAC Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230112
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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