# K233753: AI-Rad Companion (Pulmonary)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare GmbH
- Decided: Mar 21, 2024 after 120 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: 12 generations back to K913770 (1991). 139 ancestors in all.
No later device cites it as a predicate yet.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213713: AI-Rad Companion (Pulmonary), Siemens Healthcare GmbH (2022) Summary page 5.

## Indications for use
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from specialty care and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality: • Segmentation and measurements of complete lung and lung lobes • Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes • Providing an interface to external Medical Device syngo.CT Lung CAD • Segmentation and measurements of solid and sub-solid lung nodules • Dedication of found lung nodules to corresponding lung lobe • Correlation of segmented lung nodules of current scan with known priors and quantitative assessment of changes of the correlated data. • Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinguished. The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction). Only DICOM images of adult patients are considered to be valid input.

Source page: https://510kreport.com/device/K233753
Methodology: https://510kreport.com/methodology