Cleared Special

48CH Head Coil

K180666 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology
Apr 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K180666 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 April 12, 2018, 29 days after receiving the submission on March 14, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K180666 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2018
Decision Date April 12, 2018
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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