Cleared Traditional

3.0T Air MP M, 3.0T Air MP L

K182504 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology
Oct 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K182504 is an FDA 510(k) clearance for the 3.0T Air MP M, 3.0T Air MP L, 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 October 12, 2018, 30 days after receiving the submission on September 12, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K182504 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2018
Decision Date October 12, 2018
Days to Decision 30 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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