INTELLIGENT RETINAL IMAGING SYSTEMS, LLC

Address:2 North Palafox,Pensacola,FL,32502,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Management, Ophthalmic (NFJ) (1)

Premarket Exempt

Clear

IRIS - 00860001130508 Catalog Number :

Device Description : The IRIS software is a software as a service application that is hosted on the i 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.

Device Class : 2

Duns Number: 050269189

Premarket Exempt : No

Product Code : NFJ

Prescription Use : Yes

Device Count : 1

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