Ziostation2
Ziosoft, Inc.Ziostation2 is an advanced medical image processing software that supports multiple imaging modalities including CT, MRI, Ultrasound, and X-ray. It helps clinicians view and analyze medical images by providing tools for image quantification, manipulation, and communication. This software is designed to enhance the workflow and diagnostic process for radiologists and other trained medical professionals.
Intended Use
Image processing software for viewing, quantification, manipulation, communication, printing, and management of medical images from multiple modalities for use by trained medical professionals as a supplement to interpreting radiological images.
Technology
Software-based system capable of integration with networked hardware, handling DICOM images from diverse imaging modalities, providing universal functions such as data retrieval, storage, management, querying, listing, output, and invoking various imaging tools and techniques for advanced image analysis.
Performance
The software underwent integration testing and verification testing prior to validation. Regression testing was also performed on all functionality before release. Potential hazards were addressed by the Ziosoft Risk Management process.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/13/2018
2 months - 2
FDA Approval
10/9/2018
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.