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510(k) Data Aggregation
K Number
K141922Device Name
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
Manufacturer
Date Cleared
2015-02-27
(226 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in 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.
Device Description
The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam. The combination of a fundus picture and visual fields data allows a licensed/credentialed clinician to evaluate the patient for glaucoma.
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