# K213465: CardioGraphe

- Pathway: 510(k) (Traditional)
- Applicant: Arineta, Ltd.
- Decided: Dec 2, 2022 after 400 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: 8 generations back to K013561 (2001). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161066: SpotLight CT, Arineta, Ltd. (2016) Summary page 4.
- K133705: Revolution CT, Ge Medical Systems, LLC (2014) Summary page 4.

## Most influential descendants
- K230370: SpotLight/SpotLight Duo (with DLIR option) (2023), 2 descendants of its own
- K241200: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (2025), 1 descendant of its own
- K250650: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (2025), 0 descendants of its own

## Indications for use
The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

Source page: https://510kreport.com/device/K213465
Methodology: https://510kreport.com/methodology