Cleared Traditional

K113394 - MAVRIC SL

K113394 is the FDA 510(k) clearance for MAVRIC SL by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K113394 · Ge Medical Systems, LLC · Radiology device
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Dec 2012
Decision
391d
Days
Class 2
Risk

K113394 is an FDA 510(k) clearance for the MAVRIC SL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on December 11, 2012 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ge Medical Systems, LLC devices

Submission Details

510(k) Number K113394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date December 11, 2012
Days to Decision 391 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 107d · This submission: 391d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
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