Cleared Special

K003331 - QWH-149 WRIST ARRAY COIL

K003331 is the FDA 510(k) clearance for QWH-149 WRIST ARRAY COIL by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 15-day FDA review.

K003331 · Mri Devices Corp. · Radiology device
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Nov 2000
Decision
15d
Days
Class 2
Risk

K003331 is an FDA 510(k) clearance for the QWH-149 WRIST ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corp. (Waukesha, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mri Devices Corp. devices

Submission Details

510(k) Number K003331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2000
Decision Date November 08, 2000
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K003331.
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
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MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
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HRH-63 HEAD ARRAY COIL
K002774 · Mri Devices Corp. · Nov 2000
OBC-149 BREAST ARRAY COIL
K003340 · Mri Devices Corp. · Nov 2000
POWER 5000 GENERAL PURPOSE COIL
K002483 · Usa Instruments, Inc. · Oct 2000
OPART, MODEL MRT-600
K002522 · Toshiba America Mri, Inc. · Oct 2000