Cleared Special

O-Scan

K183685 · Esaote, S.P.A. · Radiology
Jan 2019
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K183685 is an FDA 510(k) clearance for the O-Scan, 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 January 22, 2019, 25 days after receiving the submission on December 28, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K183685 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2018
Decision Date January 22, 2019
Days to Decision 25 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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