Cleared Traditional

AIR Anterior Array, AIR Posterior Array

K172695 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology
Nov 2017
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K172695 is an FDA 510(k) clearance for the AIR Anterior Array, AIR Posterior Array, 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 November 22, 2017, 76 days after receiving the submission on September 7, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K172695 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2017
Decision Date November 22, 2017
Days to Decision 76 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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