IRIS

GUDID 00860001130508

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.

INTELLIGENT RETINAL IMAGING SYSTEMS, LLC

Ophthalmology PACS software

• Primary Device ID: 00860001130508
• NIH Device Record Key: c13dfbef-505c-4996-8c00-1497a6c342ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS
• Version Model Number: 3.0
• Company DUNS: 050269189
• Company Name: INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com
• Phone: 850-380-6344
• Email: fwynne@retinalscreenings.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001130508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141922

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25