# K243240: Vitrea CT VScore

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Informatics, Inc.
- Decided: Apr 10, 2025 after 182 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003230 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003230: V Score with Auto Gate Model TBD, Vital Images, Inc. (2000) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K243240
Methodology: https://510kreport.com/methodology