IRIS INTELLIGENT RETINAL IMAGING SYSTEM

INTELLIGENT RETINAL IMAGING SYSTEMS, LLC • Radiology • 02/27/2015

510(k)IEC 62304 Class B

Device Purpose

The IRIS Intelligent Retinal Imaging System is a web-based software platform designed to assist healthcare professionals in storing, managing, and reviewing ophthalmic images and diagnostic data, such as fundus photographs and visual field exams, to aid in the assessment of various eye conditions. It operates by allowing secure online transmission and access to patient information, enabling clinicians to view images, input diagnostic opinions for conditions like glaucoma and diabetic retinopathy, and formulate care plans using a HIPAA-compliant system built on the .NET framework.

Summary

The IRIS Intelligent Retinal Imaging System is a comprehensive, web-based software application designed for trained healthcare professionals to store, manage, and display patient data, diagnostic information, and ophthalmic images from computerized diagnostic instruments. It facilitates the viewing of original and color-amplified retinal images, including fundus photographs and visual field examination data, enabling remote or local review for ocular health assessment and potential diagnosis of conditions such as glaucoma. Operationally, retinal images captured via fundus cameras or visual field exam data are uploaded to the secure, internet-based platform. Licensed clinicians then review these inputs, record their opinions on suspected conditions like diabetic retinopathy, macular edema, and macular degeneration, and develop corresponding care plans. The system, built on Microsoft .NET and C#, supports DICOM and JPEG formats, ensures HIPAA compliance through data encryption, and is designed to integrate with clinic workflows for transmitting results back for patient charting.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Retinal ImagingOphthalmic Data ManagementWeb-based SoftwareFundus PhotographyVisual FieldsGlaucoma ScreeningDiabetic RetinopathyClinical Decision SupportTeleophthalmologyDICOM

Device Metadata

Submission Number

K141922

Company

INTELLIGENT RETINAL IMAGING SYSTEMS, LLC

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Generation

AI Subclass

image enhancement

Relevant Clinical Questions

Q1. Does the system offer any quantitative analysis tools or AI-assisted diagnostic suggestions beyond color amplification, or is it solely a platform for clinician review and manual data entry?; How does the system ensure data integrity and image quality during transmission and storage, especially when dealing with various fundus cameras and export formats?; What are the specific mechanisms for integrating the system's findings and care plans back into diverse electronic health record (EHR) systems used by different clinics?; Can the system track longitudinal changes in a patient's retinal images or visual field data over time to monitor disease progression or treatment efficacy?; Beyond listing suspected conditions, does the software provide structured reporting templates or standardized grading scales to guide clinicians in documenting their opinions consistently?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score40/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment✓ Detected in Summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials(remote, internet, platform)

✓ Detected

HBOMHardware Bill of Materials(camera)

✓ Detected

CBOMCryptography Bill of Materials(encryption)

✓ Detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials(operational)

✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of SaaSBOM, HBOM, CBOM, OBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, ML-BOM, VDR/VEX. These may be present in the full FDA submission.

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