# K183268: AI-Rad Companion (Cardiovascular)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 10, 2019 after 291 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: 10 generations back to K954678 (1996). 94 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990426: Calcium Scoring, Siemens Medical Solutions USA, Inc. (1999) Summary page 4.
- K123585: Syngo, CT Cardiac Function, Siemens Medical Solutions USA, Inc. (2012) Summary page 4.
- K113027: Syngo Aortic Valveguide Software, Siemens Medical Solutions USA, Inc. (2011) Summary page 5.

## Most influential descendants
- K210085: HealthCCSng (2021), 9 descendants of its own
- K230223: iCAC Device (2023), 6 descendants of its own
- K243229: Bunkerhill AVC (2025), 3 descendants of its own
- K260166: Bunkerhill Contrast CAC (2026), 0 descendants of its own
- K260167: Bunkerhill Contrast AVC (2026), 0 descendants of its own

## 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/K183268
Methodology: https://510kreport.com/methodology