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FDA 510(k)

Overjet Iris Intelligent Imaging System

K-Number: K253930 · 2026-04-10

ApplicantOverjet, Inc.
Decision Date2026-04-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Overjet Iris Intelligent Imaging System is a medical device manufactured by Overjet, Inc.. It received FDA 510(k) clearance on 2026-04-10 under approval number K253930. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Overjet Iris Intelligent Imaging System?

Overjet Iris Intelligent Imaging System is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Overjet, Inc.. The 510(k) number is K253930.

When was Overjet Iris Intelligent Imaging System approved by the FDA?

Overjet Iris Intelligent Imaging System received FDA 510(k) clearance on 2026-04-10, under approval number K253930.

What company makes Overjet Iris Intelligent Imaging System?

Overjet Iris Intelligent Imaging System is manufactured by Overjet, Inc..

What is the FDA product code for Overjet Iris Intelligent Imaging System?

The FDA product code for Overjet Iris Intelligent Imaging System is QIH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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