# K213096: Al-Rad Companion (Pulmonary)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 6, 2021 after 73 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: 14 generations back to K971684 (1997). 202 ancestors in all.
No later device cites it as a predicate yet.
3 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183271: AI-Rad Companion (Pulmonary), Siemens Medical Solutions USA, Inc. (2019) Summary page 5.
- K203699: syngo. CT Extended Functionalities, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.

## Indications for use
Al-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 emergency medicine, specialty care, urgent 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 found lung lesions and dedication to corresponding lung lobe. » 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/K213096
Methodology: https://510kreport.com/methodology