Neuviz Spiral CT Scanner System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072841 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neuviz Spiral CT Scanner System is a medical imaging device designed to produce cross-section images of the head and whole body. It functions by performing computer reconstruction of X-ray transmission data captured at various angles.
This system is authorized under FDA 510K clearance. It is intended for use in clinical imaging environments to support diagnostic procedures.
Frequently asked questions
What is the primary function of the Neuviz Spiral CT Scanner System?
This system is designed for clinical imaging environments to produce cross-section images of the head and whole body. It achieves this by performing computer reconstruction of X-ray transmission data captured at various angles to support diagnostic procedures.
What is the regulatory status of this imaging system?
The Neuviz Spiral CT Scanner System is authorized under FDA 510K clearance, identified by k-number K072841. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the Neuviz Spiral CT Scanner?
The system is manufactured by Neusoft Medical Systems Co., Ltd., located in Shenyang, Liaoning, China. The company submitted the device for traditional 510K clearance, which was granted in October 2007.
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: CT Scanner Manufacturer，Neusoft CT Scanner, Neusoft CT Scan，CT ..., Neusoft Spiral Ct Scanner System, Model Neuviz Version 2.0 (K080540 ..., Neusoft Medical USA, Neusoft Medical Systems : Medical Imaging - MedicalExpo, CT Scanners - Commonwealth X-Ray
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072841 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (1)
- FDA 510(k) K072841 24 fields · synced Sep 22, 2026