510(k) · Cleared
ClearedClearRead CT CAC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverain Technologies, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 3, 2024 as substantially equivalent to K230223 (Bunkerhill, Inc., 2023) after a 131-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Dec 3, 2024
- Review
- 131 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954678 (1996). 104 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet.
- Root · 13 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations between
- 3 generations backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- 2 generations backK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- 1 generation backK230223 iCAC DeviceBunkerhill, Inc. · 2023
- This deviceK242188 ClearRead CT CACRiverain Technologies, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 12 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 11 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 10 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 9 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 8 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 7 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 6 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 5 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 4 generations backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- 3 generations backK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- 2 generations backK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- 1 generation backK230223 iCAC DeviceBunkerhill, Inc. · 2023
- This deviceK242188 ClearRead CT CACRiverain Technologies, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −12 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −11 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −10 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −9 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −8 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −7 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −6 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −5 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −4 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −3 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −2 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| −1 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230223 | iCAC DeviceSummary page 6…intended to be used without clinical expert review. Predicate Device: Bunkerhill, Inc. (K230223) iCAC Device Class II Comparison to Predicate Device Technica… | 2023 |
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 28 years and passes through 11 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 104 ancestors have a recall of any class.
- 4 other devices also cite its predicate K230223.
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. 2024, 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?
ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older. The primary output of ClearRead CT CAC is the Agatston score. ClearRead CT CAC locates calcified coronary lesions and assigns them to one of several coronary arteries: the right coronary artery (RCA), the left main artery (LM), the…
Read the full statement (158 words)
ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older.
The primary output of ClearRead CT CAC is the Agatston score. ClearRead CT CAC locates calcified coronary lesions and assigns them to one of several coronary arteries: the right coronary artery (RCA), the left main artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (LCX). The software calculates the Agatston score as the sum for each artery while also providing the total across all coronary arteries. The total Agatston score is calibrated to 3.0mm slice thickness and is used to derive a CAC category and the arterial age. The provided segmentations are for illustrative purposes only and are not intended for diagnostic use.
ClearRead CT CAC provides adjunctive information and is not intended to be used without clinical expert review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242188 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242188: ClearRead CT CAC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242188
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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