Identifiers
- 510(k) Number
- K071154 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 Superstar 0.35T MRI System is a nuclear magnetic resonance imaging device designed for diagnostic imaging. It employs a 0.35-tesla permanent open magnet configuration to provide high-quality images across a range of clinical applications, including radiology procedures.
This system is intended for use in radiology departments and is supplied as a reusable medical device. It operates within MRI-safe environments and is authorized under FDA 510(k) clearance (K071154) as substantially equivalent to predicate devices. The system is not single-use and requires proper storage and maintenance in compliance with regulatory standards.
Frequently asked questions
What is the Superstar 0.35T MRI System intended for?
The Superstar 0.35T MRI System is a nuclear magnetic resonance imaging device designed for diagnostic imaging, providing high-quality images across a range of clinical applications in radiology procedures. It is intended for use in radiology departments.
Is the Superstar 0.35T MRI System supplied as a single-use or reusable device?
The Superstar 0.35T MRI System is supplied as a reusable medical device, meaning it is designed for multiple uses after proper cleaning, maintenance, and storage in accordance with regulatory standards.
What regulatory pathway was used for the Superstar 0.35T MRI System?
The Superstar 0.35T MRI System received FDA 510(k) clearance (K071154) as substantially equivalent to predicate devices, with a traditional clearance type and decision code SESE, indicating it was found substantially equivalent under the Federal Food, Drug, and Cosmetic Act.
What type of magnet does the Superstar 0.35T MRI System use, and where is it intended to operate?
The Superstar 0.35T MRI System employs a 0.35-tesla permanent open magnet configuration and is intended for use in MRI-safe environments within radiology departments for diagnostic imaging procedures.
What are the storage and handling requirements for the Superstar 0.35T MRI System?
The Superstar 0.35T MRI System requires proper storage and maintenance in compliance with regulatory standards to ensure safe and effective operation, as it is a reusable device intended for repeated use in clinical settings.
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: Superstar 0.35T - Neusoft Medical Latinoamérica, Neusoft - Superstar 0.35T Community, Manuals and Specifications | MedWrench, Neusoft - Superstar 0.35T Manuals and Documents | Medical, For Sale NEUSOFT Superstar 0.35T MRI Scanner - DOTmed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071154 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (1)
- FDA 510(k) K071154 24 fields · synced Sep 19, 2026