Cleared Traditional

K023247 - CHAMPION 5000 PERIPHERAL VASCULAR COIL

K023247 is an FDA 510(k) clearance for CHAMPION 5000 PERIPHERAL VASCULAR COIL, manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device width product code MOS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K023247 · Usa Instruments, Inc. · Radiology device
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Dec 2002
Decision
84d
Days
Class 2
Risk

K023247 is an FDA 510(k) clearance for the CHAMPION 5000 PERIPHERAL VASCULAR COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Usa Instruments, Inc. (Aurora, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 84 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 Usa Instruments, Inc. devices

Submission Details

510(k) Number K023247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date December 23, 2002
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K023247.
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MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K023084 · Medical Advances, Inc. · Dec 2002
GORE 3.0T TORSO ARRAY
K023679 · W.L. Gore & Associates, Inc. · Nov 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K023596 · Medrad, Inc. · Nov 2002