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Dynamic MRI Software Option for C-Scan, E-Scan XQ and E-Scan Opera

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061429

by Esaote S.p.A.

Identifiers

510(k) Number
K061429 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 device is a software package for existing Esaote C-scan, E-scan XQ, and E-scan Opera MRI systems. It acquires dynamic MR image datasets and performs post-processing to display temporal variations in image contrast.

It is supplied as a software option for use with compatible Esaote MRI systems. The device received FDA 510(k) clearance (K061429) and is classified as a Class II System, Nuclear Magnetic Resonance Imaging under product code LNH. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or specific clinical settings is provided in the data.

Frequently asked questions

What is the Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera used for?

The device is a software package that acquires dynamic MR image datasets and performs post-processing to display temporal variations in image contrast for use with compatible Esaote C-scan, E-scan XQ, and E-scan Opera MRI systems.

How is the Dynamic MRI Software Option supplied and what systems is it compatible with?

It is supplied as a software option for use with existing Esaote C-scan, E-scan XQ, and E-scan Opera MRI systems, meaning it is not a standalone system but an add-on to those specific platforms.

What regulatory pathway was used for the Dynamic MRI Software Option and what is its classification?

The device received FDA 510(k) clearance under submission K061429 and is classified as a Class II System, Nuclear Magnetic Resonance Imaging under product code LNH.

Does the device data provide information on sterility, single-use status, sizes, or storage conditions?

No information regarding sterility, single-use or reusable status, sizes, or storage conditions is provided in the device data, so these details cannot be confirmed from the available information.

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: Dynamic Mri Software Option for C-scan, E-scan Xq and E-scan Opera ..., Dynamic Mri Software Option for C-scan, E-scan Xq and E-scan Opera, K061429 FDA 510(k) - DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, PDF K061429 Dynamic Mri Software Option for C-scan, E-scan Xq and E-scan Opera

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

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

Sources (1)

  • FDA 510(k) K061429 24 fields · synced Sep 19, 2026