Cleared Special

G-scan Brio

K180592 · Esaote, S.P.A. · Radiology
Mar 2018
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K180592 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. (Genoa, IT). The FDA issued a Cleared decision on March 30, 2018, 24 days after receiving the submission on March 6, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K180592 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2018
Decision Date March 30, 2018
Days to Decision 24 days
Submission Type Special
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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