Cleared Traditional

TOSHIBA 1.5T CARDIAC COIL

K120290 · Quality Electrodynamics · Radiology
Feb 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K120290 is an FDA 510(k) clearance for the TOSHIBA 1.5T CARDIAC 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 February 28, 2012, 28 days after receiving the submission on January 31, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K120290 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2012
Decision Date February 28, 2012
Days to Decision 28 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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