Cleared Traditional

K253930 - Overjet Iris Intelligent Imaging System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253930 · Overjet, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
122d
Days
Class 2
Risk

K253930 is an FDA 510(k) clearance for the Overjet Iris Intelligent Imaging System. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Overjet, Inc. (Boston, US). The FDA issued a Cleared decision on April 10, 2026 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Overjet, Inc. devices

Submission Details

510(k) Number K253930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2025
Decision Date April 10, 2026
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 285
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K253930.
Synapse 3D Base Tools (V7.2)
K254189 · Fujifilm Corporation · Apr 2026
syngo Application Software
K254184 · Siemens Medical Solutions USA, Inc. · Apr 2026
DS Core CBCT Anatomy
K260785 · Dentsply Sirona · Apr 2026
uOmnispace.MR
K253077 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2026
Folliscan
K252332 · Mim Fertility · Apr 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · Ge Medical Systems, LLC · Apr 2026