510(k) · Cleared
ClearedCSCS-001A Calcium Scoring Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 5, 2007 as substantially equivalent to K020929 (GE Medical Systems, 2002) and 2 other predicates after an 8-day review. Its family tree reaches back 4 generations to 1995. 45 later devices descend from it.
- Decided
- Oct 5, 2007
- Review
- 8 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945512 (1995). 9 ancestors in all, the oldest K945428 (1995). 45 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 3 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 2 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 1 generation backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- This deviceK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- Descendant · cites it directly · 29 of its ownK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- Descendant · 2 generations on · 25 of its ownK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- Descendant · 3 generations on · 17 of its ownK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- Descendant · cites it directly · 14 of its ownK172983 HealthCCSZebra Medical Vision, Ltd. · 2018
- Descendant · 2 generations on · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009 · cites it directly29descendants
- K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011 · 2 generations on25descendants
- K203256Imbio RV/LV SoftwareImbio, LLC · 2021 · 3 generations on17descendants
- K172983HealthCCSZebra Medical Vision, Ltd. · 2018 · cites it directly14descendants
- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −3 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −2 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −1 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| 0 (this device) | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| +1 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| +2 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| +3 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| +1 | K172983 | HealthCCS | Zebra Medical Vision, Ltd. | 2018 | — |
| +2 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 10 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5Summary page 1…: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard Predicate Device(s): GE Smart Score (k020929) Siemens Syngo Calcium Scoring (k990436) Vital Images Vsc… | 2002 |
| * | K990426 | Calcium Scoring Our reading of the summary gave K990436, FDA’s number for Ultimax Trochanteric Intramedullary Rod System (Biodynamic Technologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Syngo Calcium Scoring”. | 1999 |
| * | K001682 | Vscore with Ekg Signal Gating | 2000 |
What descends from it? (45)
See all 452 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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K083446 (Ziosoft, Inc., 2009) has gone furthest, with 29 descendants of its own.
- 4 other devices also cite its predicate K020929.
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. 2007, 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 CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072737: CSCS-001A Calcium Scoring Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072737
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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