Skip to content

Medxion NEXUS

by medXion Technologies, Inc.

510(k) K253935

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253935 Date15 May 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OAS
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medxion Nexus is a dental computed tomography device designed to capture detailed 3D X-ray images of a patient's teeth and jaws. This imaging technology assists clinicians in achieving accurate diagnosis and treatment planning for dental care.

This device is classified as a Class 2 radiology device and has received FDA 510(k) clearance. It is identified by the product code OAS and is regulated under the 892.1750 regulation number.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the medXion NEXUS?

    The medXion NEXUS is a dental computed tomography device designed to capture detailed 3D X-ray images of a patient's teeth and jaws. This imaging technology is intended to assist clinicians in achieving accurate diagnosis and treatment planning for dental care.

  • What is the regulatory classification of this device?

    The medXion NEXUS is classified as a Class 2 radiology device. It is regulated under the 892.1750 regulation number and is identified by the product code OAS.

  • Has the medXion NEXUS received regulatory clearance?

    Yes, the medXion NEXUS has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices.