Cleared Traditional

G-scan Brio, S-scan

K161973 · Esaote, S.P.A. · Radiology
Oct 2016
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K161973 is an FDA 510(k) clearance for the G-scan Brio, S-scan, 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 October 25, 2016, 99 days after receiving the submission on July 18, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K161973 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2016
Decision Date October 25, 2016
Days to Decision 99 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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