Cleared Abbreviated

3.0T 16ch AIR AA

K223378 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology
Jan 2023
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K223378 is an FDA 510(k) clearance for the 3.0T 16ch AIR AA, 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 3, 2023, 57 days after receiving the submission on November 7, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K223378 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2022
Decision Date January 03, 2023
Days to Decision 57 days
Submission Type Abbreviated
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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