Radiology AI Directory

FDA-cleared profile

Overjet Iris Intelligent Imaging System

Overjet, Inc.

Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.

X-ray/Radiography 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
Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Dental professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Dental practices, oral and maxillofacial services, and other professional clinical settings within the labeled use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Dental radiographs, CBCT, digital impressions, photographs, or other oral and maxillofacial inputs identified in the exact FDA labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Dental or maxillofacial images, segmentations, measurements, visualizations, or planning outputs described in the exact FDA labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The image-quality output is not a substitute for professional judgment or a product-wide diagnostic claim; image type, quality, and dental reviewer scope govern applicability.
  • 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
K253930
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Teeth and maxillofacial anatomy
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-04-10
  • 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
Accepts images from intraoral sensors, panoramic machines, and consumer color cameras; cloud storage, archival, and distribution are described, but local interfaces and contract terms remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
Web and cloud storage are described; hosting region, security controls, availability, support, and service terms are unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.

Training and support
Use by the qualified healthcare professionals identified for the exact labeled workflow; site-specific competency and training requirements remain to be established locally.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-04

Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253930 before acceptance.

exact submission · checked 2026-09-04

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

Source

Interoperability acceptance

Accepts images from intraoral sensors, panoramic machines, and consumer color cameras; cloud storage, archival, and distribution are described, but local interfaces and contract terms remain unknown.

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 image-quality output is not a substitute for professional judgment or a product-wide diagnostic claim; image type, quality, and dental reviewer scope govern applicability.

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.

product family · checked 2026-09-04

No exact-product price was found in the evidence set; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.

exact submission · checked 2026-09-04

Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.

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
The exact FDA decision material reports standalone image-quality testing on 1,888 dental images reviewed by three dentists. The reported sensitivities are endpoint- and image-type-specific and are not product-wide diagnostic performance claims.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
90.8% for bitewing image-quality issues and 93.9% for periapical image-quality issues in the reported standalone dataset; this is not a diagnostic sensitivity claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product, version-specific specificity endpoint was established for this submission in the evidence set.

Bitewing image-quality sensitivity

90.8 percent

  • EndpointSensitivity for image-quality issues in bitewing images
  • Population955 bitewing images in the exact submission dataset
  • Tested versionExact FDA submission release; version not separately stated in the public decision material
Source

Periapical image-quality sensitivity

93.9 percent

  • EndpointSensitivity for image-quality issues in periapical images
  • Population933 periapical images in the exact submission dataset
  • Tested versionExact FDA submission release; version not separately stated in the public decision material
Source

Standalone image-quality validation dataset

1888 images

  • EndpointImages evaluated in standalone performance testing
  • Population955 bitewing and 933 periapical images reviewed by 3 dentists
  • Tested versionExact FDA submission release; version not separately stated in the public decision material
Source

K253930 FDA evidence package for Overjet Iris Intelligent Imaging System

  • DesignManufacturer-submitted standalone image-quality validation with three dentist reviewers; not independent clinical validation.
  • PopulationBitewing and periapical dental images in the exact Overjet Iris validation package.
  • Scopeexact submission
  • Tested versionExact FDA submission release; version not separately stated in the public decision material
  • Samplen=1888
  • IndependenceSponsor or vendor study

K253930

Evidence submitted for the exact FDA decision is not independent clinical validation. 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 configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, dental, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Reviewed CMS material is not a product-specific price or coverage determination; do not infer reimbursement from FDA clearance.

Source

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 K253930 by native exact submission identifier. This does not exclude product-family, later, 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.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
9Source 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. Exact FDA decision material was reviewed for identity and labeled use. Optional literature, trial, and recall candidates were not promoted without exact product or version applicability; commercial, security, and performance claims remain unknown where not established. 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, peer reviewed literature, clinical trial registry, reimbursement policy, 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 K253930: Overjet Iris Intelligent Imaging System

    U.S. Food and Drug Administration - Published 2026-04-10 - 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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K253930 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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