Cleared Traditional

MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR (K090526) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090526 · E-Woo Technology · Radiology device
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Dec 2009
Decision
279d
Days
Class 2
Risk

K090526 is an FDA 510(k) clearance for the MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by E-Woo Technology (Houston, US). The FDA issued a Cleared decision on December 2, 2009 after a review of 279 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.

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Submission Details

510(k) Number K090526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date December 02, 2009
Days to Decision 279 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
172d slower than avg
Panel avg: 107d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.