AI-Rad Companion Engine
Siemens Medical Solutions USA, Inc.AI-Rad Companion Engine is a software platform that supports visualization and post-processing of medical images for diagnostic use, helping clinicians by facilitating measurement, analysis, and data management. It integrates with multiple imaging modalities and PACS systems, providing an interface to add additional AI-driven clinical processing extensions.
Intended Use
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes.
Technology
The device supports multi-modality and multi-vendor DICOM data input/output, checks data validity using DICOM tags, and provides interfaces for extensions that enable post-processing functionality. It integrates with Siemens Healthineers clinical processing extensions and uses 'teamplay' infrastructure for data transfer, display, and storage.
Performance
Nonclinical bench testing, including unit, system, and integration testing, was conducted to validate software functionality and performance. The device conforms to FDA guidance for software in medical devices and multiple recognized consensus standards. No clinical tests were performed for the modifications; validation was based on software verification and nonclinical data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
7 months - 2
FDA Approval
7/10/2020
Other devices from Siemens Medical Solutions USA, Inc.
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