Cleared Traditional

K021330 - MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL

K021330 is an FDA 510(k) clearance for MAGNETOM TRIO QUADRATURE TX/RX HEAD 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 90-day FDA review.

K021330 · Usa Instruments, Inc. · Radiology device
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Jul 2002
Decision
90d
Days
Class 2
Risk

K021330 is an FDA 510(k) clearance for the MAGNETOM TRIO QUADRATURE TX/RX HEAD 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 July 25, 2002 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Usa Instruments, Inc. devices

Submission Details

510(k) Number K021330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date July 25, 2002
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 K021330.
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · Hitachi Medical Systems America, Inc. · Aug 2002
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K021631 · Mri Devices Corp. · Aug 2002
HRH-127-8 HEAD ARRAY COIL
K022372 · Mri Devices Corp. · Aug 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · Usa Instruments, Inc. · Jun 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433 · Medical Advances, Inc. · Jun 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570 · Mri Devices Corp. · Jun 2002