510(k) · Cleared
ClearedHealthCCSng
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zebra Medical Vision, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 15, 2021 as substantially equivalent to K172983 (Zebra Medical Vision, Ltd., 2018) and 1 other predicate after a 245-day review. Its family tree reaches back 11 generations to 1996. 9 later devices descend from it.
- Decided
- Sep 15, 2021
- Review
- 245 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K954678 (1996). 102 ancestors in all, the oldest K837107 (1983). 9 later devices descend from it, 4 citing it directly.
- 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 deviceK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · cites it directly · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK243229 Bunkerhill AVCBunkerHill Health · 2025
- Descendant · 2 generations on · 0 of its ownK260166 Bunkerhill Contrast CACBunkerHill Health · 2026
- Descendant · 3 generations on · 0 of its ownK260167 Bunkerhill Contrast AVCBunkerHill Health · 2026
- Descendant · 2 generations on · 0 of its ownK250662 Bunkerhill MACBunkerHill Health · 2025
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 deviceK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K230223iCAC DeviceBunkerhill, Inc. · 2023 · cites it directly6descendants
- K243229Bunkerhill AVCBunkerHill Health · 2025 · 2 generations on3descendants
- K260166Bunkerhill Contrast CACBunkerHill Health · 2026 · 2 generations on0descendants
- K260167Bunkerhill Contrast AVCBunkerHill Health · 2026 · 3 generations on0descendants
- K250662Bunkerhill MACBunkerHill Health · 2025 · 2 generations on0descendants
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) | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +1 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +2 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
| +2 | K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026 | — |
| +3 | K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026 | — |
| +2 | K250662 | Bunkerhill MAC | BunkerHill Health | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K172983 | HealthCCSSummary page 4…e Device: The HealthCCSng device is substantially equivalent to the following Primary Predicate Device: Proprietary Name HealthCCS Premarket Notification K172983 Classification Name Computed tomography x-ray system. Regulation Number 21 CFR 892.1750 Product Code… | 2018 |
| * | K183268 | AI-Rad Companion (Cardiovascular)Summary page 4…R 892.1750 Product Code JAK Regulatory Class II Secondary Predicate Device: Proprietary Name AI-Rad Companion Premarket Notification K183268 Classification Name Computed tomography x-ray system. Regulation Number 21 CFR 892.1750 Zebra Medical Vision Ltd.… | 2019 |
What descends from it? (9)
4 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 25 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 20 of the 102 ancestors have a recall of any class.
- Of its descendants, K230223 (Bunkerhill, Inc., 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K172983.
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. 2021, 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?
The HealthCCSng device 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. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output…
Read the full statement (126 words)
The HealthCCSng device 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. The software generates an estimated coronary artery calcium detection category.
The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.
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/K210085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210085: HealthCCSng.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210085
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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