Cleared Traditional

SHOULDER SPEEDER COIL

K093667 · Quality Electrodynamics · Radiology
Jan 2010
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K093667 is an FDA 510(k) clearance for the SHOULDER SPEEDER COIL, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on January 28, 2010, 62 days after receiving the submission on November 27, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K093667 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2009
Decision Date January 28, 2010
Days to Decision 62 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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