Cleared Traditional

K143128 - mDIXON XD

K143128 is the FDA 510(k) clearance for mDIXON XD by Philips Medical Systems Nederlands B.V.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K143128 · Philips Medical Systems Nederlands B.V. · Radiology device
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Mar 2015
Decision
141d
Days
Class 2
Risk

K143128 is an FDA 510(k) clearance for the mDIXON XD. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems Nederlands B.V. (Best, NL). The FDA issued a Cleared decision on March 20, 2015 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Philips Medical Systems Nederlands B.V. devices

Submission Details

510(k) Number K143128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2014
Decision Date March 20, 2015
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.

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