Cleared Special

TOSHIBA 3T EXTRA LARGE KNEE COIL

K112313 · Quality Electrodynamics · Radiology
Sep 2011
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K112313 is an FDA 510(k) clearance for the TOSHIBA 3T EXTRA LARGE KNEE 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 September 9, 2011, 29 days after receiving the submission on August 11, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K112313 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2011
Decision Date September 09, 2011
Days to Decision 29 days
Submission Type Special
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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