Cleared Traditional

G-scan Brio

K142421 · Esaote, S.P.A. · Radiology
Apr 2015
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K142421 is an FDA 510(k) clearance for the G-scan Brio, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Esaote, S.P.A. (Genova, IT). The FDA issued a Cleared decision on April 9, 2015, 224 days after receiving the submission on August 28, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K142421 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2014
Decision Date April 09, 2015
Days to Decision 224 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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