510(k) Report

510(k) · Cleared

Cleared

CT VScore+

K252217510(k) TraditionalCleared Nov 28, 2025136-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Canon Medical Informatics, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 28, 2025 as substantially equivalent to K213725 (GE Medical Systems SCS, 2022) after a 136-day review. Its family tree reaches back 5 generations to 1995.

Decided
Nov 28, 2025
Review
136 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K945512 (1995). No later device cites it as a predicate yet.

Reference device: K243240 · Vitrea CT VScore · Canon Medical Informatics, Inc. · 2025K945512 · HRSW Option for CT Twin Flash · Elscint, Inc. · 1995K970980 · Cardiac Scoring for CT Scanners · Elscint, Inc. · 1997K982004 · CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows · General Electric Co. · 1998K020929 · Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 · GE Medical Systems · 2002K213725 · CardIQ Suite · GE Medical Systems SCS · 20221995200020052010201520202025
K213725 · CardIQ Suite · GE Medical Systems SCS · 2022K020929 · Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 · GE Medical Systems · 2002K982004 · CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows · General Electric Co. · 1998K970980 · Cardiac Scoring for CT Scanners · Elscint, Inc. · 1997K945512 · HRSW Option for CT Twin Flash · Elscint, Inc. · 1995−50
  1. Root · 5 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
  2. 4 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
  3. 3 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
  4. 2 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
  5. 1 generation backK213725 CardIQ SuiteGE Medical Systems SCS · 2022
  6. This deviceK252217 CT VScore+Canon Medical Informatics, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945512HRSW Option for CT Twin FlashElscint, Inc.1995—
−4K970980Cardiac Scoring for CT ScannersElscint, Inc.1997—
−3K982004CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage WindowsGeneral Electric Co.1998—
−2K020929Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems2002—
−1K213725CardIQ SuiteGE Medical Systems SCS2022—
0 (this device)K252217CT VScore+Canon Medical Informatics, Inc.2025—
FIG. 1 — Lineage of K252217, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K213725CardIQ Suite
Summary page 6
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name Product Code K213725 GE CardIQ Suite JAK Device Description Summary…
GE Medical Systems SCS2022—
†K243240Vitrea CT VScoreCanon Medical Informatics, Inc.2025—

Also cleared against K213725: 1 other device →

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 30 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • None of the 5 ancestors has a recall.
  • 1 other device also cites its predicate K213725.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the…

Read the full statement (151 words)

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The segmented arteries include combined LM+LAD, RCA, and LCX. To obtain separate LM and LAD results, the user must perform manual segmentation. The segmentation map of calcifications is intended for informational use only and is not intended for detection or diagnostic purposes. The 3D Calcium View output is provided strictly as an informational and supplementary output and should never be used alone as the method of reviewing the calcium segmentation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K213725

1 other device cites the same predicate.

  • K233731CardIQ SuiteGE Medical Systems SCS · 2024

More from Canon Medical Informatics, Inc.

5 FDA decisions under this applicant name. See the company

  • K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · 2026
  • K243240Vitrea CT VScoreCanon Medical Informatics, Inc. · 2025
  • K223261Open RibCanon Medical Informatics, Inc. · 2023
  • K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc. · 2022

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K252217 · printed Nov 6, 2026

Cite this page

510(k) Report. “K252217: CT VScore+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252217

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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