# K183272: AI Rad Companion (Engine)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 1, 2019 after 70 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: 13 generations back to K913770 (1991). 183 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170952: syngo.CT View&GO, Siemens Medical Solutions USA, Inc. (2017) Summary page 4.

## Most influential descendants
- K193294: AI-Rad Companion Engine (2020), 0 descendants of its own
- K200899: Quantib AI Node (2020), 0 descendants of its own

## Indications for use
AI-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension 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 means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions. AI-Rad Companion (Engine) functionality includes: • Interface for multi-modality and multi-vendor Input / Output of DICOM Data • Check of data validity using information for 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/K183272
Methodology: https://510kreport.com/methodology