Cleared Traditional

K111305 - UNIVERSAL DIGITAL INTERFACE WIRELESS - ...

K111305 is an FDA 510(k) clearance for UNIVERSAL DIGITAL INTERFACE WIRELESS - ..., manufactured by Meridian Medical Systems, LLC. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K111305 · Meridian Medical Systems, LLC · Radiology device
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Jan 2012
Decision
267d
Days
Class 2
Risk

K111305 is an FDA 510(k) clearance for the UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Meridian Medical Systems, LLC (Aurora, US). The FDA issued a Cleared decision on January 31, 2012 after a review of 267 days - an extended review cycle.

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: 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 Meridian Medical Systems, LLC devices

FDA 510(k) Submission Details - K111305

510(k) Number K111305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2011
Decision Date January 31, 2012
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
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 287
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K111305.
VIVIX-S
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K120477 · Konica Minolta Medical & Graphic, Inc. · Apr 2012
REGIUS SIGMA2
K120131 · Konica Minolta Medical & Graphic, Inc. · Feb 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630 · Rayence Co., Ltd. · Dec 2011
INFINIX-CCI
K113052 · Toshiba America Medical Systems, In.C · Nov 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · Fujifilm Medical System U.S.A., Inc. · Sep 2011