Cleared Traditional

K151926 - QuickRay HD Intraoral Sensor

K151926 is an FDA 510(k) clearance for QuickRay HD Intraoral Sensor, manufactured by Denterprise International, Inc.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K151926 · Denterprise International, Inc. · Radiology device
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Dec 2015
Decision
153d
Days
Class 2
Risk

K151926 is an FDA 510(k) clearance for the QuickRay HD Intraoral Sensor. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Denterprise International, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on December 14, 2015 after a review of 153 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Denterprise International, Inc. devices

FDA 510(k) Submission Details - K151926

510(k) Number K151926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2015
Decision Date December 14, 2015
Days to Decision 153 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 107d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

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

All 90
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K151926.
Televere Digital Dental Imaging System
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System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
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Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
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EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · Rayence Co., Ltd. · Jul 2015
Digital Dental Intra Oral Sensor, EzSensor Smart
K150797 · Rayence Co., Ltd. · May 2015