Cleared Special

K252570 - EzSensor HD, EzSensor UHD (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252570 · Qpix Solutions, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2025
Decision
88d
Days
Class 2
Risk

K252570 is an FDA 510(k) clearance for the EzSensor HD, EzSensor UHD. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Qpix Solutions, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 10, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Qpix Solutions, Inc. devices

Submission Details

510(k) Number K252570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 Consultant

Mtech Group, LLC
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 205
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