Cleared Traditional

K091090 - DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717

K091090 is an FDA 510(k) clearance for DIGITAL FLAT PANEL X-RAY DETECTOR, manufactured by E-Woo Technology. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 480-day FDA review.

K091090 · E-Woo Technology · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
480d
Days
Class 2
Risk

K091090 is an FDA 510(k) clearance for the DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by E-Woo Technology (Houston, US). The FDA issued a Cleared decision on August 9, 2010 after a review of 480 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all E-Woo Technology devices

FDA 510(k) Submission Details - K091090

510(k) Number K091090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2009
Decision Date August 09, 2010
Days to Decision 480 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
373d slower than avg
Panel avg: 107d · This submission: 480d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 296
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K091090.
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · Fujifilm Medical Systems U.S.A, Inc. · Mar 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K101590 · VATECH Co., Ltd. · Nov 2010
WIRELESS DR IMAGING OPTION-WDR1
K102615 · Ge Medical Systems, LLC · Nov 2010
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
K101289 · Air Techniques, Inc. · Aug 2010
FLAT PANEL DETECTOR, MODEL FDR D-EVO
K100762 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427 · Fujifilm Medical System U.S.A., Inc. · Jan 2010