Cleared Traditional

K002860 - MODEL 6900GE-64: C-SPINE ARRAY

K002860 is an FDA 510(k) clearance for MODEL 6900GE-64: C-SPINE ARRAY, manufactured by Midwest Rf, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K002860 · Midwest Rf, LLC · Radiology device
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Nov 2000
Decision
70d
Days
Class 2
Risk

K002860 is an FDA 510(k) clearance for the MODEL 6900GE-64: C-SPINE ARRAY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Midwest Rf, LLC (Hartland, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 70 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 Midwest Rf, LLC devices

FDA 510(k) Submission Details - K002860

510(k) Number K002860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date November 22, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 107d · This submission: 70d
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 339
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K002860.
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097 · Image-Guided Neurologics, Inc. · Jan 2001
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · Medical Advances, Inc. · Dec 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K003144 · Medical Advances, Inc. · Dec 2000
HRH-63 HEAD ARRAY COIL
K002774 · Mri Devices Corp. · Nov 2000
QWH-149 WRIST ARRAY COIL
K003331 · Mri Devices Corp. · Nov 2000
OBC-149 BREAST ARRAY COIL
K003340 · Mri Devices Corp. · Nov 2000