Cleared Traditional

SPEEDER 1.5T WRIST ARRAY COIL

K072935 · Quality Electrodynamics · Radiology
Oct 2007
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K072935 is an FDA 510(k) clearance for the SPEEDER 1.5T WRIST ARRAY 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 October 31, 2007, 14 days after receiving the submission on October 17, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K072935 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2007
Decision Date October 31, 2007
Days to Decision 14 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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