Identity
- Trade Name
- IRIS FDA UDI
- Generic Name
- Ophthalmology PACS software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001130508 FDA UDI
- 510(k) Number
- K141922 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Ophthalmology PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Ophthalmology PACS software
Iris by Intelligent Retinal Imaging Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmology PACS software.
- IMAGEnet 6 OPHTHALMIC DATA SYSTEM — Topcon Corp. · Class II
- AXIS Image Management System — SONOMED, INC. · Class II
- Continuum PACS — INTEGRATED OPHTHALMIC SYSTEMS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Intelligent Retinal Imaging Systems, LLC
Sources (1)
- FDA UDI c13dfbef-505c-4996-8c00-1497a6c342ae 35 fields · synced Jun 6, 2026