Cleared Special

Magnifico Open (100009900); Magnifico MSK ( 100009910)

K241133 · Esaote, S.P.A. · Radiology
Jun 2024
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K241133 is an FDA 510(k) clearance for the Magnifico Open (100009900); Magnifico MSK ( 100009910), 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 June 26, 2024, 63 days after receiving the submission on April 24, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K241133 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2024
Decision Date June 26, 2024
Days to Decision 63 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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