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Magnifico Open (100009900); Magnifico MSK (100009910)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241133

by Esaote S.p.A.

Identifiers

510(k) Number
K241133 FDA 510(k)
FDA Product Code
LNH FDA 510(k)
Models / Variants
Magnifico Open (100009900) FDA 510(k)EUDAMED
Magnifico MSK ( 100009910) FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Magnifico Open and Magnifico MSK are System, Nuclear Magnetic Resonance Imaging devices, designed for high-field magnetic resonance imaging (MRI) of the musculoskeletal system and general anatomy. These open-configuration MRI systems provide access for patients with claustrophobia or those requiring treatment during imaging, while delivering detailed soft-tissue contrast and multiplanar imaging capabilities.

These devices are intended for use in clinical radiology settings and are supplied as reusable systems with MRI-compatible components. Both models are classified as Class II under 21 CFR 892.1000, with the Magnifico Open (100009900) and Magnifico MSK (100009910) receiving FDA 510(k) clearance and MDR authorization. They are not single-use and require proper maintenance, calibration, and storage in accordance with manufacturer guidelines to ensure MRI safety and performance.

Frequently asked questions

What are the primary use cases for the Magnifico Open and Magnifico MSK MRI systems in a clinical setting?

The Magnifico Open and Magnifico MSK are designed for high-field magnetic resonance imaging (MRI) of both general anatomy and the musculoskeletal system. Their open-configuration design makes them particularly suitable for patients who experience claustrophobia or require concurrent treatment during imaging, such as wound care or physical therapy. Both models provide detailed soft-tissue contrast and multiplanar imaging, enhancing diagnostic accuracy for radiology applications.

Are the Magnifico Open and Magnifico MSK MRI systems single-use or reusable, and what does this mean for maintenance?

The Magnifico Open and Magnifico MSK are reusable systems, meaning they are built for long-term use in clinical radiology settings. This requires adherence to manufacturer guidelines for proper maintenance, calibration, and storage to ensure MRI safety, performance, and compliance with regulatory standards. Reusability also implies that components must be regularly inspected and serviced to maintain imaging quality and prevent degradation over time.

How do the regulatory pathways differ between the Magnifico Open and Magnifico MSK models?

Both models share the same regulatory classification as Class II devices under 21 CFR 892.1000, with FDA 510(k) clearance and MDR authorization. The key distinction lies in their specialized design intent: the Magnifico Open prioritizes accessibility for claustrophobic patients or those needing concurrent treatment, while the Magnifico MSK is optimized for musculoskeletal imaging. Neither model implies a difference in regulatory approval—both are cleared for general MRI use with their respective design advantages.

What storage or environmental conditions are required for these MRI systems to ensure optimal performance?

While the device data does not specify exact storage conditions, reusable MRI systems like the Magnifico Open and MSK require controlled environmental settings to protect components from physical damage, electromagnetic interference, and temperature fluctuations. Manufacturer guidelines (not detailed here) typically recommend dry, temperature-stabilized spaces away from direct sunlight or moisture, along with proper shielding to maintain MRI safety and imaging accuracy. Always follow Esaote’s operational manual for site-specific requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Magnifico Open (100009900); Magnifico MSK ( 100009910), Magnifico Open (100009900); Magnifico MSK ( 100009910) - beudamed.com, K241133 - Magnifico Open (100009900) - FDA 510 (k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Esaote S.p.A.
FDA Applicant
Esaote, S.p.A.

Sources (2)

  • FDA 510(k) K241133 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026