510(k) · Cleared

Cleared

Vitrea CT VScore

K243240510(k) TraditionalCleared Apr 10, 2025182-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 Apr 10, 2025 as substantially equivalent to K003230 (Vital Images, Inc., 2000) after a 182-day review. Its family tree reaches back 1 generation to 2000.

Decided: Apr 10, 2025
Review: 182 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003230 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003230 V Score with Auto Gate Model TBDVital Images, Inc. · 2000
This deviceK243240 Vitrea CT VScoreCanon Medical Informatics, Inc. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003230	V Score with Auto Gate Model TBD	Vital Images, Inc.	2000	—
0 (this device)	K243240	Vitrea CT VScore	Canon Medical Informatics, Inc.	2025	—

FIG. 1 — Lineage of K243240, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003230	V Score with Auto Gate Model TBD Summary page 5 …21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K003230 11 VSCORE WITH AUTO GATE MODEL…	Vital Images, Inc.	2000	—

Also cleared against K003230: 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?

Its one ancestor has no recall.
1 other device also cites its predicate K003230.

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

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

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

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

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 Vitrea CT VScore™ option is a calcium scoring application intended for the visualization, evaluation, and documentation of calcified lesions on non-contrast ECG-gated, cardiac CT DICOM images for patients aged 30 years or older. The application allows the user to segment and categorize the calcified lesions and calculate the calcium scores. The user can create a report including the data, images, literature, and additional relevant information. The…

Read the full statement (104 words)

The Vitrea CT VScore™ option is a calcium scoring application intended for the visualization,

evaluation, and documentation of calcified lesions on non-contrast ECG-gated, cardiac CT DICOM

images for patients aged 30 years or older. The application allows the user to segment and

categorize the calcified lesions and calculate the calcium scores. The user can create a report

including the data, images, literature, and additional relevant information. The application is intended

to be used by qualified medical professionals to assist the physician in medical imaging assessment

based on their professional judgment and other patient information. The calcification segmentation

map is intended for informational use only.

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

https://510kreport.com/device/K243240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243240: Vitrea 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/K243240

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