Magnifico Open, Magnifico MSK
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212419 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
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 open-configuration nuclear magnetic resonance imaging (MRI) systems designed for musculoskeletal and general radiology applications. These devices utilize permanent magnet technology to provide high-resolution diagnostic imaging without the constraints of traditional closed-bore systems, accommodating patients with claustrophobia or large body habitus. Their open architecture supports a range of imaging protocols tailored for soft tissue, joint, and bone assessments in clinical and research settings.
These MRI systems are supplied as reusable medical devices, intended for use in radiology departments or specialized imaging centers. The Magnifico Open and Magnifico MSK are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance and MDR authorization. They are not MRI-conditional for specific environments but are designed for standard radiology use. No single-use or sterile packaging is specified; maintenance and calibration follow manufacturer guidelines to ensure compliance with regulatory standards.
Frequently asked questions
What types of patients can benefit from using the Magnifico Open or Magnifico MSK MRI systems, and why is this design advantageous?
The Magnifico Open and Magnifico MSK MRI systems are specifically designed for patients who experience claustrophobia or have a large body habitus, as their open-configuration eliminates the confined space of traditional closed-bore MRI machines. This design also makes them suitable for musculoskeletal and general radiology imaging, allowing high-resolution scans of soft tissue, joints, and bones without the limitations of conventional systems.
Are the Magnifico Open and Magnifico MSK MRI systems intended for single-use or reusable applications?
The Magnifico Open and Magnifico MSK MRI systems are supplied as reusable medical devices. They are intended for long-term use in radiology departments or specialized imaging centers, with maintenance and calibration following manufacturer guidelines to ensure compliance with regulatory standards.
What regulatory pathways have the Magnifico Open and Magnifico MSK MRI systems undergone, and what does this mean for their use?
The Magnifico Open and Magnifico MSK MRI systems have received FDA 510(k) clearance and MDR authorization, confirming they meet regulatory requirements for safety and performance. These systems are classified as Class II devices under FDA regulations and are designed for standard radiology use, not for MRI-conditional environments.
How are the Magnifico Open and Magnifico MSK MRI systems supplied, and what should be considered regarding their maintenance?
The systems are supplied as reusable medical devices, meaning they are not packaged for single-use or sterile applications. Proper maintenance and calibration are essential to ensure compliance with regulatory standards and optimal performance, as outlined by the manufacturer.
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: the next generation in Open MRI - Esaote, Magnifico - MSK Imaging, Magnifico Open, Magnifico MSK (K212419) — FDA 510 (k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212419 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K212419 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026