Cleared Traditional

K103342 - 3.0T METAFLEXCOIL

K103342 is an FDA 510(k) clearance for 3.0T METAFLEXCOIL, manufactured by Neocoil, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K103342 · Neocoil, LLC · Radiology device
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Dec 2010
Decision
38d
Days
Class 2
Risk

K103342 is an FDA 510(k) clearance for the 3.0T METAFLEXCOIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Neocoil, LLC (Pewaukee, US). The FDA issued a Cleared decision on December 23, 2010 after a review of 38 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 Neocoil, LLC devices

FDA 510(k) Submission Details - K103342

510(k) Number K103342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date December 23, 2010
Days to Decision 38 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 313
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K103342.
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