Cleared Traditional

K133986 - 1.5T ORBIT AND MANDIBLE ARRAY

K133986 is an FDA 510(k) clearance for 1.5T ORBIT AND MANDIBLE ARRAY, manufactured by Resonance Innovations, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K133986 · Resonance Innovations, LLC · Radiology device
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Jan 2014
Decision
32d
Days
Class 2
Risk

K133986 is an FDA 510(k) clearance for the 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Resonance Innovations, LLC (Omaha, US). The FDA issued a Cleared decision on January 27, 2014 after a review of 32 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 Resonance Innovations, LLC devices

FDA 510(k) Submission Details - K133986

510(k) Number K133986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date January 27, 2014
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
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 329
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