# K252217: CT VScore+

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Informatics, Inc.
- Decided: Nov 28, 2025 after 136 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: 5 generations back to K945512 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213725: CardIQ Suite, GE Medical Systems SCS (2022) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K252217
Methodology: https://510kreport.com/methodology