Cleared Special

MRI Dynamic Analysis Plus

K153039 · Esaote, S.P.A. · Radiology
Jan 2016
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K153039 is an FDA 510(k) clearance for the MRI Dynamic Analysis Plus, 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 January 8, 2016, 81 days after receiving the submission on October 19, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K153039 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2015
Decision Date January 08, 2016
Days to Decision 81 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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