IRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEMS, LLCThe IRIS Intelligent Retinal Imaging System is a web-based software that stores, manages, and displays retinal images and diagnostic data from computerized instruments. It allows licensed clinicians to review fundus images and visual field data to evaluate and diagnose retinal conditions such as diabetic retinopathy, glaucoma, and macular degeneration, thereby assisting in patient care and follow-up.
Intended Use
A comprehensive web-based software system for storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals.
Technology
Software as a Service (SaaS) application hosted on the internet. Accepts fundus images in DICOM and JPEG formats and visual field data. Uses Microsoft .NET platform with C# programming, providing a web-based image management and review platform for licensed clinicians to input discrete diagnostic opinions and care plans.
Performance
No new clinical performance data was required; software validation and verification showed the system performs as intended, supporting substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/16/2014
7 months - 2
FDA Approval
2/27/2015
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