NeuViz 128 Multi-Slice CT Scanner System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230220 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 128 Multi-Slice CT Scanner System is a computed tomography (CT) device designed for high-resolution cross-sectional imaging of the human body. It employs a 128-slice detector array to acquire detailed volumetric data, enabling rapid and precise visualization of anatomical structures for diagnostic purposes. This system supports a range of clinical applications, including cardiovascular, neurological, and abdominal imaging, where fine detail and low-dose radiation are critical. Its advanced detector technology and reconstruction algorithms enhance image clarity and reduce artifacts, improving diagnostic confidence.
The NeuViz 128 is intended for use in radiology departments within hospitals or specialized imaging centers. It is supplied as a reusable medical device, requiring proper installation, calibration, and maintenance by trained personnel. The system is classified under the FDA’s product code JAK and has received FDA 510K clearance and MDR compliance, confirming its regulatory standing. Storage and operational conditions must adhere to manufacturer guidelines to ensure optimal performance and patient safety, with no specific sterility requirements stated for the device itself.
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: Multi Slice CT Scanner - Neusoft Medical, NeuViz 128 — Neusoft Medical USA, CT Scanner Manufacturer，Neusoft CT Scanner, Neusoft CT Scan，CT ..., NeuViz 128 Multi-Slice CT Scanner System - physicianaitools.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230220 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (2)
- FDA 510(k) K230220 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026