Cleared Traditional

K013514 - PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY ...

K013514 is the FDA 510(k) clearance for PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY ... by Mri Devices Corp.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K013514 · Mri Devices Corp. · Radiology device
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Jan 2002
Decision
72d
Days
Class 2
Risk

K013514 is an FDA 510(k) clearance for the PHSL-63 PEDIATRIC HEAD AND SPINE 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 January 2, 2002 after a review of 72 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 Mri Devices Corp. devices

Submission Details

510(k) Number K013514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date January 02, 2002
Days to Decision 72 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 107d · This submission: 72d
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 310
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K013514.
PREMIER III PHASED ARRAY CTL SPINE COIL
K013595 · 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
SHOULDER COIL
K013541 · Usa Instruments, Inc. · Dec 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · Usa Instruments, Inc. · Dec 2001
NURVO 9000 ENDOCAVITARY COILS
K011683 · Usa Instruments, Inc. · Dec 2001