Cleared Traditional

Magnifico Open, Magnifico MSK

K212419 · Esaote, S.P.A. · Radiology
Feb 2022
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K212419 is an FDA 510(k) clearance for the Magnifico Open, Magnifico MSK, 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 February 4, 2022, 184 days after receiving the submission on August 4, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K212419 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2021
Decision Date February 04, 2022
Days to Decision 184 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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