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O-Scan MR System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K092469

by Esaote S.p.A.

Identifiers

510(k) Number
K092469 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 O-Scan MR System is a Nuclear Magnetic Resonance Imaging (MRI) System designed for diagnostic imaging. It generates detailed images of the internal structures of the body using magnetic fields and radio waves, enabling radiologists to assess anatomical and pathological conditions in soft tissues, organs, and musculoskeletal systems with high contrast resolution.

This system is intended for use in radiology departments within clinical settings, where it is operated by trained radiologic technologists or physicians. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure MRI safety compliance, including compliance with MRI safety standards for the specified field strengths. The system is authorized under FDA 510(k) clearance and the Medical Devices Directive (MDD), with regulatory classification as a Class II device.

Frequently asked questions

What types of medical imaging can the O-Scan MR System be used for, and why is it particularly useful for certain conditions?

The O-Scan MR System is designed for Nuclear Magnetic Resonance Imaging (MRI), which generates high-contrast images of soft tissues, organs, and musculoskeletal systems. This makes it particularly useful for diagnosing conditions like tumors, joint disorders, spinal issues, and neurological abnormalities where detailed visualization of soft tissues is critical. The system’s ability to differentiate between various tissue types enhances its utility in radiology for assessing anatomical and pathological conditions.

Is the O-Scan MR System intended for single-use or reusable applications, and what maintenance is required?

The O-Scan MR System is supplied as a reusable medical device, meaning it is not designed for single-use. Since it operates within MRI environments, it requires regular maintenance and calibration to ensure MRI safety compliance, including adherence to standards for specified field strengths. Proper upkeep is essential to maintain imaging accuracy and patient safety.

What regulatory pathways has the O-Scan MR System followed, and how does this affect its use in clinical settings?

The O-Scan MR System has been authorized under FDA 510(k) clearance and the Medical Devices Directive (MDD), classifying it as a Class II device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets safety and performance standards. Clinicians can rely on its compliance with these pathways, ensuring it meets established benchmarks for MRI systems in radiology departments.

How is the O-Scan MR System typically deployed in a clinical environment, and who operates it?

The O-Scan MR System is intended for use in radiology departments within clinical settings. It is operated by trained radiologic technologists or physicians, who are responsible for conducting MRI scans, interpreting images, and ensuring proper use of the system. Its design supports integration into existing workflows for diagnostic imaging.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

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) K092469 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026