# K183271: AI-Rad Companion (Pulmonary)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 26, 2019 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: 10 generations back to K913770 (1991). 137 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123540: Syngo CT Pulmo 3D, Siemens Medical Systems, Inc. (2013) Summary page 4.
- K093621: Syngo.Pet&CT Oncology, Siemens Medical Solutions USA, Inc. (2010) Summary page 5.

## Most influential descendants
- K203699: syngo. CT Extended Functionalities (2021), 3 descendants of its own
- K213713: AI-Rad Companion (Pulmonary) (2022), 1 descendant of its own
- K214019: syngo.CT Extended Functionality (2022), 1 descendant of its own
- K233753: AI-Rad Companion (Pulmonary) (2024), 0 descendants of its own
- K221727: syngo.CT Extended Functionality (2022), 0 descendants of its own

## 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 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. 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/K183271
Methodology: https://510kreport.com/methodology