Cleared Traditional

K112527 - UNIVERSAL DIGITAL INTERFACE (UDI) 1717

K112527 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 265-day FDA review.

K112527 · Meridian Medical Systems, LLC · Radiology device
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May 2012
Decision
265d
Days
Class 2
Risk

K112527 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 May 22, 2012 after a review of 265 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.

FDA 510(k) Submission Details - K112527

510(k) Number K112527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2011
Decision Date May 22, 2012
Days to Decision 265 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 107d · This submission: 265d
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K112527.
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K113812 · Atlaim · May 2012