MRI Magnetic Resonance Analytical Software System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994283 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)
This device is a Nuclear Magnetic Resonance Imaging System designed for analytical processing of MRI data. It functions as a software solution to enhance, quantify, and analyze images generated by MRI scanners, supporting diagnostic and research applications in radiology. The system performs tasks such as segmentation, measurement, and post-processing to derive clinically relevant insights from MRI scans. It is classified as a Class II medical device under FDA regulations, indicating moderate risk and requiring pre-market notification (510(k)) clearance.
The MRI Magnetic Resonance Analytical Software System is intended for use in radiology departments and clinical research settings, where it operates on compatible MRI systems to process and analyze imaging data. Supplied as a software-only solution, it is installed on standard computing platforms and does not require physical sterilization or single-use protocols. The system is non-MRI conditional, meaning it must be used outside the MRI environment to avoid interference. Authorized under FDA 510(k) clearance (K994283), it adheres to regulatory standards for software-as-a-medical-device (SaMD) applications, ensuring compliance with 21 CFR Part 892.1000 for nuclear magnetic resonance imaging systems.
Frequently asked questions
What is the MRI Magnetic Resonance Analytical Software System used for?
The MRI Magnetic Resonance Analytical Software System is designed to process and analyze MRI scan data, enabling radiologists and researchers to enhance, quantify, and derive clinically relevant insights from images. It performs tasks such as segmentation, measurement, and post-processing to improve diagnostic accuracy and support research applications in radiology.
How is the MRI Magnetic Resonance Analytical Software System supplied?
This system is supplied exclusively as a software-only solution. It is installed on standard computing platforms and does not require any physical hardware or sterilization procedures. Users must ensure compatibility with their MRI systems and operate the software outside the MRI environment to avoid interference.
Is the MRI Magnetic Resonance Analytical Software System single-use or reusable?
The software is intended for reusable use within compatible MRI systems and computing environments. Since it is a software solution, it does not have a physical lifespan tied to single-use constraints. However, regular software updates and maintenance are recommended to ensure optimal performance and compliance with regulatory standards.
Does the MRI Magnetic Resonance Analytical Software System require sterilization?
No, the software does not require sterilization as it is a non-physical, software-based solution. Sterilization is only applicable to physical medical devices, and this system operates entirely through digital processing on standard computing platforms.
What regulatory approval does the MRI Magnetic Resonance Analytical Software System hold?
The system holds FDA 510(k) clearance under the reference number K994283, indicating it has been classified as a Class II medical device and deemed substantially equivalent to a predicate device. This clearance ensures compliance with regulatory standards for software-as-a-medical-device (SaMD) applications, specifically adhering to 21 CFR Part 892.1000 for nuclear magnetic resonance imaging systems.
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: Magnetic resonance imaging - Wikipedia, Cardiac Imaging Software - Medis Medical Imaging, Magnetresonanztomographie – Wikipedia, medisimaging - Medical Imaging Software - Medis Suite MR overview, Mri- Magnetic Resonance Analytical Software System 510 (k) FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994283 | Class II | Active |
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Manufacturer
- Manufacturer
- Medis Medical Imaging Systems bv
Sources (1)
- FDA 510(k) K994283 24 fields · synced Oct 1, 2026