Cleared Traditional

K103335 - GEM OPTION FOR 1.5 MRI SYSTEMS

K103335 is an FDA 510(k) clearance for GEM OPTION FOR 1.5 MRI SYSTEMS, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K103335 · Ge Healthcare · Radiology device
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Mar 2011
Decision
112d
Days
Class 2
Risk

K103335 is an FDA 510(k) clearance for the GEM OPTION FOR 1.5 MRI SYSTEMS. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Healthcare (Aurora, US). The FDA issued a Cleared decision on March 7, 2011 after a review of 112 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.

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FDA 510(k) Submission Details - K103335

510(k) Number K103335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date March 07, 2011
Days to Decision 112 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
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 428
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K103335.
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