Superopen 0.23T MRI System Modification, Model NAM-P023A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082485 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 Superopen 0.23T MRI System Modification, Model NAM-P023A, is a magnetic resonance imaging (MRI) device designed for non-invasive imaging of internal anatomical structures. It generates transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, or extremities without ionizing radiation. This modification enhances the existing 0.23T MRI system’s capabilities for diagnostic imaging purposes. The device adheres to the classification of an MRI system as defined by regulatory standards.
This MRI system modification is intended for use in clinical settings, providing detailed anatomical visualization for diagnostic evaluation. It is supplied as a reusable device, requiring proper maintenance and calibration to ensure MRI safety and image quality. The system operates within a 0.23 Tesla magnetic field strength and must comply with MRI safety protocols, including shielding and patient safety guidelines. The modification holds FDA clearance under 510(k) approval (K082485) and is regulated under the Product Code LNH for radiology imaging devices.
Frequently asked questions
What is the Superopen 0.23T MRI System Modification NAM-P023A used for?
The Superopen 0.23T MRI System Modification, Model NAM-P023A, is designed for non-invasive diagnostic imaging of internal anatomical structures. It produces transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, or extremities. This modification enhances the existing 0.23T MRI system’s capabilities, enabling detailed visualization for clinical evaluation without using ionizing radiation.
Is the Superopen 0.23T MRI System Modification NAM-P023A a single-use or reusable device?
This MRI system modification is a reusable device. Proper maintenance and calibration are required to ensure MRI safety and consistent image quality. Regular upkeep is essential to comply with MRI safety protocols, including shielding and patient safety guidelines.
What magnetic field strength does the Superopen 0.23T MRI System Modification NAM-P023A operate at?
The device operates within a 0.23 Tesla magnetic field strength, which is standard for this modification of the Superopen MRI system. This field strength is suitable for generating detailed anatomical images for diagnostic purposes while adhering to MRI safety standards.
How is the Superopen 0.23T MRI System Modification NAM-P023A supplied?
The modification is supplied as part of an existing 0.23T MRI system infrastructure, requiring integration into the current setup. It is not sold as a standalone unit but rather as an upgrade to enhance imaging capabilities. Proper installation and compliance with MRI safety protocols are necessary before use.
What regulatory approval does the Superopen 0.23T MRI System Modification NAM-P023A hold?
The modification holds FDA clearance under the 510(k) approval process, specifically under the clearance number K082485. It is classified under Product Code LNH for radiology imaging devices and was determined to be substantially equivalent to a predicate device by the FDA’s Radiology Advisory Committee.
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: Modification to Superopen 0.23t Mri System, Model Nam-p023a, MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A by NEUSOFT MEDICAL ..., Modification to Superopen 0.23t Mri System, Model Nam-p023a
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082485 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (1)
- FDA 510(k) K082485 24 fields · synced Oct 1, 2026