Cleared Traditional

K103599 - UNIVERSAL DIGITAL INTERFACE (UDI) 1717

K103599 is an FDA 510(k) clearance for UNIVERSAL DIGITAL INTERFACE (UDI) 1717, 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 140-day FDA review.

K103599 · Meridian Medical Systems, LLC · Radiology device
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Apr 2011
Decision
140d
Days
Class 2
Risk

K103599 is an FDA 510(k) clearance for the UNIVERSAL DIGITAL INTERFACE (UDI) 1717. 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 April 27, 2011 after a review of 140 days - within the typical 510(k) review window.

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 - K103599

510(k) Number K103599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date April 27, 2011
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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 K103599.
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · Fujifilm Medical System U.S.A., Inc. · Aug 2011
REGUIS SIGMA
K103703 · Konica Minolta Medical & Graphic, Inc. · Jun 2011
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
K111098 · Imaging Dynamics Company , Ltd. · May 2011
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