Cleared Traditional

K093348 - 3.0T 16 CHANNEL HEAD NECK SPINE COIL

K093348 is the FDA 510(k) clearance for 3.0T 16 CHANNEL HEAD NECK SPINE COIL by Ge Healthcare Coils (Usa Instruments, Inc.). It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K093348 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device
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Nov 2009
Decision
29d
Days
Class 2
Risk

K093348 is an FDA 510(k) clearance for the 3.0T 16 CHANNEL HEAD NECK SPINE COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Waukesha, US). The FDA issued a Cleared decision on November 25, 2009 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Healthcare Coils (Usa Instruments, Inc.) devices

Submission Details

510(k) Number K093348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2009
Decision Date November 25, 2009
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 299
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K093348.
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