510(k) clearance

EzSensor HD

FDA 510(k) source

510(k) number

K261663

Applicant

Qpix Solutions, Inc.

Decision date

Sep 30, 2026

Date received

May 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MUH

Device type

System, X-Ray, Extraoral Source, Digital

Device class

Class II

Regulation

21 CFR 872.1800

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Morrisville, NC, US