Cleared Traditional

K103185 - TOSHIBA 1.5T EXTRA LARGE KNEE COIL

K103185 is an FDA 510(k) clearance for TOSHIBA 1.5T EXTRA LARGE KNEE COIL, manufactured by Quality Electrodynamics. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K103185 · Quality Electrodynamics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
120d
Days
Class 2
Risk

K103185 is an FDA 510(k) clearance for the TOSHIBA 1.5T EXTRA LARGE KNEE COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on February 25, 2011 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quality Electrodynamics devices

FDA 510(k) Submission Details - K103185

510(k) Number K103185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2010
Decision Date February 25, 2011
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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 K103185.
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