Cleared Special

EzSensor HD, EzSensor UHD

K252570 · Qpix Solutions, Inc. · Radiology
Nov 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K252570 is an FDA 510(k) clearance for the EzSensor HD, EzSensor UHD, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Qpix Solutions, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 10, 2025, 88 days after receiving the submission on August 14, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K252570 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2025
Decision Date November 10, 2025
Days to Decision 88 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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