# K222662: Vitrea CT Cardiac Analysis

- Pathway: 510(k) (Special)
- Applicant: Canon Medical Informatics, Inc.
- Decided: Oct 14, 2022 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052632: VITREA2 Version 3.8 Medical Image Processing Software, Vital Images, Inc. (2005) Summary page 4.

## Indications for use
Vitrea® Coronary Artery Analysis (CT Cardiac Analysis) is intended for investigating coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit statistics.

Source page: https://510kreport.com/device/K222662
Methodology: https://510kreport.com/methodology