Cleared Special

K143232 - Universal Digital Interface 2W

K143232 is an FDA 510(k) clearance for Universal Digital Interface 2W, manufactured by Meridian Medical Systems, LLC. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 81-day FDA review.

K143232 · Meridian Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
81d
Days
Class 2
Risk

K143232 is an FDA 510(k) clearance for the Universal Digital Interface 2W, UDI 2W. 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 30, 2015 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Meridian Medical Systems, LLC devices

FDA 510(k) Submission Details - K143232

510(k) Number K143232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date January 30, 2015
Days to Decision 81 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

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 K143232.
AeroDR SYSTEM 2
K151465 · Konica Minolta, Inc. · Jun 2015
Carestream DRX-1 System
K150766 · Carestream Health, Inc. · Jun 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150 · Rayence Co., Ltd. · Mar 2015
RIS500
K143000 · Ray Co., Ltd. · Jan 2015
EVS 4343
K142475 · DRTECH Corporation · Jan 2015
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003 · Fujifilm Medical System U.S.A., Inc. · Oct 2014