# K222360: AI-Rad Companion (Cardiovascular)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions U.S.A.
- Decided: Apr 6, 2023 after 245 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: 11 generations back to K954678 (1996). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183268: AI-Rad Companion (Cardiovascular), Siemens Medical Solutions USA, Inc. (2019) Summary page 5.

## Indications for use
AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: - Segmentation and volume measurement of the heart - Quantification of the total calcium volume in the coronary arteries - Segmentation of the aorta - Measurement of maximum diameters of the aorta at typical landmarks - Threshold-based highlighting of enlarged diameters The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM images of adult patients are considered to be valid input.

Source page: https://510kreport.com/device/K222360
Methodology: https://510kreport.com/methodology