eRAD PACS
eRAD, Inc.eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.
Intended Use
eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces. It is intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images from multiple DICOM-compliant modalities including CT, MRI, mammography, nuclear medicine, PET, ultrasound, x-ray angiography, and others.
Technology
eRAD PACS is composed of a central systems manager, diagnostic viewing components, and an archiving component. It acquires patient and procedure info and medical images from various sources, retrieves prior procedure data, and renders images on user workstations for review and optional reporting. The software is now restructured for deployment in a cloud environment but maintains the fundamental technology unchanged.
Performance
Non-clinical system verification and validation testing was conducted in accordance with standards and internal design procedures to verify that the software meets user needs and intended use. Testing demonstrated substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/1/2024
6 months - 2
FDA Approval
10/31/2024
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