S-Scan, G-Scan Dynamic MRI Software for C-Scan, E-ScanXQ & E-Scan Opera
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080968 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 and G-Scan Dynamic MRI Software is a diagnostic imaging system designed for use with Esaote’s C-Scan, E-ScanXQ, and E-Scan Opera MRI platforms. It enables dynamic MRI imaging, allowing for the capture and analysis of time-resolved sequences to assess physiological motion, perfusion, or functional changes in tissues.
This software is intended for use in radiology settings and is supplied as a digital product for installation on compatible MRI systems. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. The software operates in non-sterile environments and is reusable, with no specific sterility requirements beyond standard MRI system maintenance.
Frequently asked questions
What MRI platforms is the S-Scan and G-Scan Dynamic MRI Software compatible with?
The S-Scan and G-Scan Dynamic MRI Software is designed exclusively for use with Esaote’s C-Scan, E-ScanXQ, and E-Scan Opera MRI platforms. It is not compatible with other MRI systems unless explicitly stated by Esaote.
How is the S-Scan and G-Scan software supplied, and what are the installation requirements?
The software is supplied as a digital product, meaning it is not a physical device but rather a downloadable or installable program. It must be installed on compatible Esaote MRI systems (C-Scan, E-ScanXQ, or E-Scan Opera) to function. No additional hardware is required beyond the host MRI system.
Is the S-Scan and G-Scan software reusable, and are there any sterility requirements?
Yes, the software is reusable as it operates in a non-sterile environment. Since it is a digital product installed on MRI systems, there are no sterility requirements beyond standard maintenance protocols for the MRI system itself, as outlined in the manufacturer’s guidelines.
What types of physiological assessments can the S-Scan and G-Scan software support?
The software enables dynamic MRI imaging to capture and analyze time-resolved sequences, allowing for the assessment of physiological motion, perfusion, or functional changes in tissues. This makes it useful for evaluating dynamic processes in radiology settings.
What regulatory pathways has the S-Scan and G-Scan Dynamic MRI Software undergone?
The software has received FDA 510(k) clearance and MDD authorization, confirming its compliance with U.S. and European regulatory standards. It is classified as a Class II medical device under FDA regulations, indicating a moderate risk level that requires premarket notification.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K080968 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (2)
- FDA 510(k) K080968 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026