AI Rad Companion (Engine)
Siemens Medical Solutions USA, Inc.AI Rad Companion (Engine) by Siemens Medical Solutions is a software platform designed to assist technicians and physicians in viewing, processing, and analyzing medical images from multiple modalities. It supports integration with PACS systems and allows external AI-based post-processing extensions, improving clinical image analysis and workflow.
Intended Use
AI-Rad Companion (Engine) is a software platform providing basic visualization and enabling external post-processing extensions for medical images used for diagnostic purposes. It supports technicians and physicians in qualitative and quantitative analysis of clinical data and integrates with PACS systems.
Technology
The software platform supports multi-modality and multi-vendor DICOM input/output, validity checking of DICOM tags, interfaces for post-processing extensions, and user interfaces for configuring the device and confirming processed images. It has been updated to deploy on Siemens cloud infrastructure with improved extension access and visualization workflows.
Performance
Non-clinical testing including software validation, bench testing, unit and system integration testing have been conducted. Testing demonstrated conformity with FDA-recognized standards for medical software and imaging. Risk analysis and mitigation were implemented. Usability and human factors studies were conducted. The device was found to be safe and effective for its intended use and supports substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2018
2 months - 2
FDA Approval
2/1/2019
Other devices from Siemens Medical Solutions USA, Inc.
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