# K193294: AI-Rad Companion Engine

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 10, 2020 after 226 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K913770 (1991). 184 ancestors in all.
No later device cites it as a predicate yet.
3 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183272: AI Rad Companion (Engine), Siemens Medical Solutions USA, Inc. (2019) Summary page 5.

## Indications for use
Al-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides the means for viewing, storing and transferring data into other systems such as PACS systems. The software platform also provides an interface to integrate additional Siemens Healthineers' clinical processing extensions. Al-Rad Companion Engine functionality includes: - Interface for multi-modality and multi-vendor Input/Output of DICOM data - Check of data validity using information of DICOM tags - Interface for extensions that provide post-processing functionality - Confirmation user interface for visualization of medical images processed by extensions - Configuration user interface for configuration of the medical device and extensions

Source page: https://510kreport.com/device/K193294
Methodology: https://510kreport.com/methodology