Cleared Traditional

K031536 - BRAIN COIL, MODEL 9900GE-64

K031536 is an FDA 510(k) clearance for BRAIN COIL, manufactured by Clinical MR Solutions, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K031536 · Clinical MR Solutions, LLC · Radiology device
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Jul 2003
Decision
63d
Days
Class 2
Risk

K031536 is an FDA 510(k) clearance for the BRAIN COIL, MODEL 9900GE-64. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Clinical MR Solutions, LLC (Brookfield, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 63 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 Clinical MR Solutions, LLC devices

FDA 510(k) Submission Details - K031536

510(k) Number K031536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2003
Decision Date July 18, 2003
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
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 385
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K031536.
QSC-127 SHOULDER ARRAY COIL SET
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PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
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SENSE BODY COIL
K031095 · Philips Medical Systems (Cleveland), Inc. · Jun 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K031139 · Usa Instruments, Inc. · May 2003