Cleared Traditional

K013595 - PREMIER III PHASED ARRAY CTL SPINE COIL

K013595 is an FDA 510(k) clearance for PREMIER III PHASED ARRAY CTL SPINE COIL, 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 84-day FDA review.

K013595 · Usa Instruments, Inc. · Radiology device
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Jan 2002
Decision
84d
Days
Class 2
Risk

K013595 is an FDA 510(k) clearance for the PREMIER III PHASED ARRAY CTL SPINE 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 January 22, 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

FDA 510(k) Submission Details - K013595

510(k) Number K013595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2001
Decision Date January 22, 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 K013595.
CTL BODY / SPINE ARRAY COIL
K014086 · Usa Instruments, Inc. · Feb 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036 · Mri Devices Corp. · Feb 2002
BODY ARRAY COIL
K013594 · Usa Instruments, Inc. · Jan 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · Philips Medical Systems North America, Inc. · Jan 2002
EXTREMITY COIL
K013592 · Usa Instruments, Inc. · Jan 2002
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514 · Mri Devices Corp. · Jan 2002