Radiology AI Directory

FDA-cleared profile

IRIS INTELLIGENT RETINAL IMAGING SYSTEM

INTELLIGENT RETINAL IMAGING SYSTEMS, LLC

The IRIS Intelligent Retinal Imaging System is a comprehensive web-based software application for 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.

Ophthalmic Imaging workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
The IRIS Intelligent Retinal Imaging System is a comprehensive web-based software application for 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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained healthcare professionals who review ophthalmic patient and diagnostic data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Ophthalmic image-management environments within the labeled scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Storage, management, display, and review of patient, diagnostic, and ophthalmic image data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Patient data, diagnostic data, and images from supported computerized diagnostic instruments or systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Original and color-amplified images and associated patient or diagnostic records for trained-professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The exact indication describes image management and viewing; it does not establish a disease-detection, sensitivity, specificity, or treatment-decision claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K141922
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ophthalmic Imaging
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Ophthalmic diagnostic images and associated patient data
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2015-02-27
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact public FDA decision material does not establish a complete integration contract. Confirm supported inputs, outputs, identity, routing, archive behavior, audit behavior, and downtime locally.

Deployment and data flow
The exact FDA indication describes a web-based software application; current hosting, service responsibility, security, availability, and site configuration remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is a partial release-level topology fact from the exact FDA package; current hosting, contracts, security, availability, and site configuration remain separate evidence.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only trained healthcare professionals who review ophthalmic patient and diagnostic data should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K141922 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The exact indication describes image management and viewing; it does not establish a disease-detection, sensitivity, specificity, or treatment-decision claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K141922 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared or authorized release includes them.

Source

Deployment boundary

The exact FDA indication describes a web-based software application; current hosting, service responsibility, security, availability, and site configuration remain unknown.

exact submission · checked 2026-09-04

FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The exact indication describes image management and viewing; it does not establish a disease-detection, sensitivity, specificity, or treatment-decision claim.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

exact submission · checked 2026-09-04

No exact-product price or reimbursement determination was promoted.

Source

Lifecycle monitoring

Monitor K141922 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The exact indication describes image management and viewing; it does not establish a disease-detection, sensitivity, specificity, or treatment-decision claim.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K141922 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K141922 FDA decision evidence package for IRIS INTELLIGENT RETINAL IMAGING SYSTEM

  • DesignFDA decision evidence and product verification described in the exact submission or PMA decision record.
  • PopulationOphthalmic diagnostic images and associated patient data
  • Scopeexact submission
  • Tested versionIRIS INTELLIGENT RETINAL IMAGING SYSTEM configuration described in K141922
  • IndependenceSponsor or vendor study

K141922

FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K141922 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-04Last searched
26Fields reviewed
6Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

This submission was added after the prior exact-submission extraction and remains queued for source review. Scope was limited to exact FDA decision material and exact-submission recall disposition already present in the checked snapshot. Optional literature, vendor, pricing, and deployment research was not promoted. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision material, fda device recall, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K141922: IRIS INTELLIGENT RETINAL IMAGING SYSTEM

    U.S. Food and Drug Administration - Published 2015-02-27 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K141922 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed