510(k) · Cleared
ClearedHealthCCS
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 Jun 13, 2018 as substantially equivalent to K072737 (Toshiba America Medical Systems, In.C, 2007) after a 259-day review. Its family tree reaches back 5 generations to 1995. 14 later devices descend from it.
- Decided
- Jun 13, 2018
- Review
- 259 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945512 (1995). 10 ancestors in all, the oldest K945428 (1995). 14 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 4 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 3 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 2 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 1 generation backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- This deviceK172983 HealthCCSZebra Medical Vision, Ltd. · 2018
- 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 · cites it directly · 3 of its ownK192763 syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK201034 Syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · cites it directly9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 2 generations on6descendants
- K243229Bunkerhill AVCBunkerHill Health · 2025 · 3 generations on3descendants
- K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · 2019 · cites it directly3descendants
- K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −4 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −3 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −2 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −1 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| 0 (this device) | K172983 | HealthCCS | Zebra Medical Vision, Ltd. | 2018 | — |
| +1 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +2 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +3 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
| +1 | K192763 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +2 | K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K072737 | CSCS-001A Calcium Scoring PackageSummary page 4…vice: The HealthCCS device is substantially equivalent to the following device: Proprietary Name CSCS-001A Calcium Scoring Package Premarket Notification K072737 (5 Oct. 2007) Classification Name Computed tomography x-ray system Regulation Number 21 CFR 892.1750 Product C… | 2007 |
| † | K053347 | Kodak Carestream Pacs | 2006 |
What descends from it? (14)
See all 142 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 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K210085 (Zebra Medical Vision, Ltd., 2021) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K072737.
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. 2018, 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 HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest…
Read the full statement (139 words)
The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest ECG-Gated/Triggered CT scans. The Device is indicated for use only on patients whose age at the time, when the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician’s own judgment. It may require further testing to evaluate the appropriate clinical management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172983: HealthCCS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172983
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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