Cleared Traditional

K113394 - MAVRIC SL

K113394 is an FDA 510(k) clearance for MAVRIC SL, manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K113394

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.

LNH Device Classification - Class 2, Special Controls

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 969
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