Change Healthcare Stratus Imaging PACS
Change Healthcare Canada CompanyChange Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.
Intended Use
Software-based medical image management and processing system intended to process and display medical images for diagnostic viewing and interpretation by qualified and trained healthcare professionals.
Technology
Cloud-based medical image management and processing system with zero-footprint, browser-based diagnostic viewer supporting DICOM standard images, post-processing including image manipulation, enhancement, measurement, annotations, comparison, and 3D/4D visualization. Integrates with third-party tools and operates on approved web browsers and commercially available hardware.
Performance
Software verification and validation testing were conducted according to company quality management and FDA guidance documents, demonstrating that the device meets acceptance criteria without raising new safety or effectiveness questions compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/5/2024
4 months - 2
FDA Approval
11/12/2024
Other devices from Change Healthcare Canada Company
- Change Healthcare Anatomical AI2021 • 510K
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