Cleared Traditional

K050514 - MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS

K050514 is an FDA 510(k) clearance for MODELS FAC-63 AND FAC-127 FOOT AND ANKL..., manufactured by Mri Devices Corporation. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K050514 · Mri Devices Corporation · Radiology device
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Mar 2005
Decision
24d
Days
Class 2
Risk

K050514 is an FDA 510(k) clearance for the MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mri Devices Corporation (Pewaukee, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 24 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 Corporation devices

FDA 510(k) Submission Details - K050514

510(k) Number K050514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2005
Decision Date March 25, 2005
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

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 368
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K050514.
QD KNEE/FOOT COIL, MODEL MJQJ-147A
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K042718 · Siemens Medi Cal Solutions, Inc. · Nov 2004
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K042617 · Siemens Medical Solutions USA, Inc. · Nov 2004