Cleared Traditional

Magnifico Open (100009900)

K251901 · Esaote, S.P.A. · Radiology
Mar 2026
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K251901 is an FDA 510(k) clearance for the Magnifico Open (100009900), 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 March 5, 2026, 258 days after receiving the submission on June 20, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K251901 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2025
Decision Date March 05, 2026
Days to Decision 258 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

Similar Devices — LNH System, Nuclear Magnetic Resonance Imaging

All 1093
Embrace Neonatal MRI System
K254277 · Aspect Imaging, Ltd. · Mar 2026
LiverMultiScan (v6.0)
K253413 · Perspectum, Ltd. · Mar 2026
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
K260265 · Siemens Shenzhen Magnetic Resonance , Ltd. · Feb 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
K253648 · Philips Medical Systems Nederland B.V. · Feb 2026
SIGNA? Bolt
K253780 · Ge Medical Systems, LLC · Feb 2026
SIGNA? Sprint Select
K253779 · Ge Medical Systems, LLC · Feb 2026