Cleared Traditional

48CH Head Coil

K163205 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology
Jan 2017
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K163205 is an FDA 510(k) clearance for the 48CH Head Coil, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on January 12, 2017, 58 days after receiving the submission on November 15, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K163205 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2016
Decision Date January 12, 2017
Days to Decision 58 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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