Cleared Traditional

TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL

K091114 · Quality Electrodynamics · Radiology
May 2009
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K091114 is an FDA 510(k) clearance for the TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD 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 May 1, 2009, 14 days after receiving the submission on April 17, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K091114 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2009
Decision Date May 01, 2009
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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