510(k) · Cleared
ClearediCAC Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bunkerhill, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 25, 2023 as substantially equivalent to K210085 (Zebra Medical Vision, Ltd., 2021) after an 89-day review. Its family tree reaches back 12 generations to 1996. 6 later devices descend from it.
- Decided
- Apr 25, 2023
- Review
- 89 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). 6 later devices descend from it, 5 citing it directly.
- 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 deviceK230223 iCAC DeviceBunkerhill, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK243229 Bunkerhill AVCBunkerHill Health · 2025
- Descendant · cites it directly · 0 of its ownK260166 Bunkerhill Contrast CACBunkerHill Health · 2026
- Descendant · 2 generations on · 0 of its ownK260167 Bunkerhill Contrast AVCBunkerHill Health · 2026
- Descendant · cites it directly · 0 of its ownK250662 Bunkerhill MACBunkerHill Health · 2025
- Descendant · cites it directly · 0 of its ownK242188 ClearRead CT CACRiverain Technologies, Inc. · 2024
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 deviceK230223 iCAC DeviceBunkerhill, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K243229Bunkerhill AVCBunkerHill Health · 2025 · cites it directly3descendants
- K260166Bunkerhill Contrast CACBunkerHill Health · 2026 · cites it directly0descendants
- K260167Bunkerhill Contrast AVCBunkerHill Health · 2026 · 2 generations on0descendants
- K250662Bunkerhill MACBunkerHill Health · 2025 · cites it directly0descendants
- K242188ClearRead CT CACRiverain Technologies, Inc. · 2024 · cites it directly0descendants
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) | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +1 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
| +1 | K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026 | — |
| +2 | K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026 | — |
| +1 | K250662 | Bunkerhill MAC | BunkerHill Health | 2025 | — |
| +1 | K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | 2024 | — |
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 | 1 | 0 |
| 2024 | 1 | 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 K243229 Bunkerhill AVCscore 21.4 · 13 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…JAK Regulatory Class II Predicate Device Proprietary Name HealthCCSng Manufactured by Zebra Health Premarket Notification K210085 Classification Name Computed tomography x-ray system Regulation Number 21 CFR 892.1750 Product Code… | 2021 |
What descends from it? (6)
5 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 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.
- Of its descendants, K243229 (BunkerHill Health, 2025) has gone furthest, with 3 descendants of its own.
- 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?
iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category…
Read the full statement (237 words)
iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient’s coronary artery calcium burden in Agatston units.
The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated calcium score or score group can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan; both are still available to be viewed and used at the discretion of the physician.
The device is intended to provide information to the physician to provide assistance during review of the patient’s case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient’s results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230223: iCAC Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230223
Report an extraction error
Are you the manufacturer?
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