Cleared Traditional

K021262 - MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD...

K021262 is an FDA 510(k) clearance for MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD..., manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K021262 · Usa Instruments, Inc. · Radiology device
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May 2002
Decision
29d
Days
Class 2
Risk

K021262 is an FDA 510(k) clearance for the MAGNETOM SYMPHONY 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 May 21, 2002 after a review of 29 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

FDA 510(k) Submission Details - K021262

510(k) Number K021262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2002
Decision Date May 21, 2002
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 K021262.
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570 · Mri Devices Corp. · Jun 2002
OBC-127 BREAST ARRAY COIL
K021575 · Mri Devices Corp. · Jun 2002
GPF-29 GENERAL PURPOSE COIL SET
K020850 · Mri Devices Corp. · Jun 2002
NVA-63-8 NEUROVASCULAR ARRAY COIL
K020606 · Mri Devices Corp. · Mar 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854 · Usa Instruments, Inc. · Feb 2002
CTL BODY / SPINE ARRAY COIL
K014086 · Usa Instruments, Inc. · Feb 2002