← Back to catalogue

S-Scan MRI System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K063207

by Esaote S.p.A.

Identifiers

510(k) Number
K063207 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 S-Scan MRI System is a Nuclear Magnetic Resonance Imaging System (OpenFDA classification: LNH) designed for high-resolution soft-tissue visualization. It employs advanced magnetic resonance technology to generate detailed cross-sectional images of internal body structures, facilitating diagnostic evaluation in radiology.

This system is intended for use in clinical radiology settings and is supplied as a reusable medical device. It is not classified as single-use and requires adherence to MRI safety protocols, including compliance with electromagnetic interference standards. The device holds FDA 510(k) clearance and MDD compliance, with regulatory registration numbers listed under OpenFDA (e.g., 3008156140). Storage and maintenance follow manufacturer guidelines to ensure operational integrity and patient safety.

Frequently asked questions

What types of medical imaging does the S-Scan MRI System specialize in, and why is this important for clinical use?

The S-Scan MRI System specializes in high-resolution soft-tissue visualization, which is critical for detailed imaging of internal structures like muscles, organs, and joints. This capability is particularly important in radiology for diagnosing conditions such as tumors, musculoskeletal injuries, or neurological disorders where soft-tissue contrast is essential.

Is the S-Scan MRI System intended for single-use or reusable applications, and what does this mean for maintenance?

The S-Scan MRI System is designed as a reusable medical device, meaning it is not meant for single-use. This requires adherence to strict maintenance protocols to ensure operational integrity, patient safety, and compliance with electromagnetic interference standards. Regular servicing and cleaning are necessary to sustain performance and longevity.

What regulatory approvals does the S-Scan MRI System hold, and how does this impact its use in clinical settings?

The S-Scan MRI System holds FDA 510(k) clearance and MDD compliance, indicating it meets U.S. and European regulatory standards for safety and effectiveness. This approval ensures it can be legally used in clinical radiology settings in both the U.S. and Europe, provided all manufacturer guidelines and safety protocols are followed.

How should the S-Scan MRI System be stored to maintain its operational integrity and safety?

The S-Scan MRI System must be stored according to the manufacturer’s guidelines to preserve its functionality and ensure patient safety. This includes proper environmental conditions, protection from electromagnetic interference, and adherence to maintenance schedules. Specific storage instructions are detailed in the device’s operational manual.

What safety protocols must be followed when using the S-Scan MRI System, particularly regarding electromagnetic interference?

The S-Scan MRI System requires strict compliance with MRI safety protocols to mitigate electromagnetic interference risks. This includes ensuring all personnel and equipment within the MRI environment adhere to safety guidelines, such as avoiding metallic objects and following manufacturer-recommended procedures to prevent interference with imaging quality or patient safety.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (2)

  • FDA 510(k) K063207 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026