Cleared Special

K130457 - 3T DISTAL COIL

K130457 is an FDA 510(k) clearance for 3T DISTAL COIL, manufactured by Resonance Innovations, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 87-day FDA review.

K130457 · Resonance Innovations, LLC · Radiology device
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May 2013
Decision
87d
Days
Class 2
Risk

K130457 is an FDA 510(k) clearance for the 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL. 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 May 20, 2013 after a review of 87 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Resonance Innovations, LLC devices

FDA 510(k) Submission Details - K130457

510(k) Number K130457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date May 20, 2013
Days to Decision 87 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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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