Cleared Traditional

K090526 - MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR

K090526 is an FDA 510(k) clearance for MEDICAL IMAGE PROCESSING UNIT, manufactured by E-Woo Technology. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K090526 · E-Woo Technology · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all E-Woo Technology devices

FDA 510(k) Submission Details - K090526

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.

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 99
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K090526.
PLANMECA PROMAX 3D MAX
K093590 · Planmeca Oy · May 2010
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K092171 · Genoray Co., Ltd. · Apr 2010
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
K100317 · VATECH Co., Ltd. · Mar 2010
MYRAY SKYVIEW
K081088 · Cefla S.C. · Nov 2008
XIOS PLUS WALL-MODULE
K081903 · Sirona Dental Systems GmbH · Aug 2008
DENTAL DIGITAL X-RAY IMAGING SYSTEM
K073365 · VATECH Co., Ltd. · Apr 2008